European Stars and Stripes (Newspaper) - January 12, 1990, Darmstadt, Hesse                                Pages the stars and stripes Friday january 12,1990 Fra revokes its approval of Jarvik mechanical heart Washington a the food and drug administration has withdrawn approval for All uses of the Jarvik artificial heart in humans citing poor manufacturing and other deficiencies an Agency spokesman said wednesday. The Agency Felt the deficiencies were great enough that risks to patients were outweighing benefits said Jeff Nesbit. An Fra spokesman. The manufacturer symbiont inc. Of Tempe. Ariz., had received Fra approval to allow its mechanical heart to be used experimentally both As a permanent artificial heart and As a temporary Bridge for people awaiting a human heart transplant. Approvals for both uses of the artificial heart were revoked As was the company s approval for an acute ventricular assist device. The company s designation for its artificial heart formerly known As the Jarvik-7. Is the symbiont j-7.the Developer or. Rob Ert Jarvik. Is no longer associated with symbiont. While symbiont sold the Only approved Perma nent artificial heart other companies have approvals for devices that arc used As temporary Bridges. Fra conducted two inspections of the company s facilities last year and found some serious deficiencies Nesbit said. He said that some aspects of manufacturing Quality were found to be poor enough to endanger patients and that the company had failed to report unexpected Adverse events to the Fra As required. He said the Agency also found that research Sites were not being monitored properly and that servicing of equipment and training of personnel was inadequate. Symbiont had received approval to implant its per manent heart in As Many As seven people As part of a continuing Experiment. Nesbit said it was possible that the company could discuss the problems with the Fra and Correct them but he declined to say How Likely it was that the Fra would reconsider its decision. A letter announcing the Fra s decision was sent to the company on monday. Jarvik the Jarvik-7 artificial heart symbiont issued a statement saying it had received the Fra notice and would release further information at the appropriate  last week a 57-year-old Missouri woman who held the record for living the longest on an artificial heart before receiving a human heart transplant died of a heart attack. Carolyn Stadler of St. Charles had lived 440 Days with the artificial bean before receiving a human heart her second last fall. There have been Only a handful of artificial heart used in humans and recipients hav. Been plagued by clotting and strokes. Interest in the artificial heart remains High be cause experts believe 20,000 to 75,000 americans could use a transplant but there Are not enough donors. In 1988, there were 1,630 transplants in the United states. Stateside sick boy who was promised Home run by babe Ruth Dies Mineola. . A John Dale Johnny Sylvester who became the most famous Little sick boy in America after babe Ruth promised to smack a world series Homer for him and hit three has died 63 years later. He was 74. Sylvester died monday at a Mincola Hospital. No cause of death was  1926, Sylvester was suffering from a serious infection of the forehead caused by a kick from horse when he told his father. I wish i could  babe Ruth Wallop a Homer before i  family sent telegrams to the new York Yankees while the team was playing in St.  came an airmail package containing two baseballs one autographed by the St. Louis cardinals the other signed by several Yankees including Ruth who wrote ill Knock a Homer for you on  hit three that Day. In a follow up note the Day of game 6, Ruth said he would try to Knock you another Homer maybe two today but went no Merliss. He hit one in game 7, but it was no enough to prevent the Yankees from losing the series. In fact Ruth was caught stealing for the final  visited the Essex fells no. Boy at his bedside after the  miraculous recovery occurred but the visit certainly did no harm. It took Sylvester three years before he fully recovered. Sylvester returned the gesture in 1948, visiting Ruth four months before the slugger died of cancer. 3 separate bombs explode at University in Michigan Rochester Mich. A three bomb exploded on the Oakland University Campus leading school officials to cancel thursday classes while police investigated. No injuries were reported and no threats were received before wednesday s explosions. No suspects nor motives were known said Jim Llewellyn spokesman for the 12,000-Stu Dent school about 30 Miles North of  said the University would remain closed thursday while the investigation  first explosion occurred about 5 15 . On the fourth floor of the Kresge Library Llewel Lyn said. Several books were damaged but there was no fire and several students on the floor escaped he  the same time an explosion in the Library parking lot damaged a parked car Llewellyn  7 ., a bomb exploded in the parking lot but caused no known damage he said. Unknown youth keeps helping victims of Hugo Charleston . A each week since Hurricane Hugo smashed into South Carolina a Plain envelope addressed in a child s hand and usually containing $1 has arrived at the local american red Cross office. The envelopes apparently contain portion of an unidentified Pennsylvania youth s allowance. Red Cross director Glenn Ellis said wednesday. Agency officials would like to thank the child for his or her generosity which now amounts to about si7 but have no idea who he or she May be Ellis said. The Only clue is a postmark of Rossiter pa., a Community of about 750 people located about 65 Miles Northeast of Pitts Burgh. A is Bill was enclosed in each of the envelopes except one that contained 58 cents. The Only writing on the envelope was the address of the red Cross office and the designation it was to be used for Hugo Relief. Red Cross officials plan to Contact newspapers that serve tic Rossiter area in an attempt to try to find the youth. Meanwhile although the red Cross has stopped its fund raising for Hugo Relief Money continues to arrive each Day. The most amazing thing is the kids Ellis said adding that one child sent $ 1.25, saying he wanted to give his week s allow Ance to the Relief Effort. In the Days before Christmas the red Cross got More offers of toys and gifts Thanet could handle and had to ask other Agen cies to handle the distribution. The generosity of the american peo ple is just amazing he said. We still get Money every Day. We have stopped our fund raising. But every Day we still gel , More than $129 million was raised by the red Cross for Hurri Cane and earthquake Relief in the carib bean the . Mainland and  $9.3 million of that has been spent in South  Hugo s 135 Mph winds smashed into South Carolina on sept.21, causing an estimated $6 billion dam age and claiming 29 lives. Poor design led to fatal collapse of school Wall Albany . A raws in the design of an elementary school cafeteria Wall that collapsed and killed nine children in november left it unable to with stand High winds state officials concluded wednesday. Students at the East Coldenham elementary school near Newburgh were unaware of severe weather warn Ings during a storm nov. 16, said a report by the state disaster preparedness commission. The commission in the first official account of the causes of the disaster recommended improved review of new school construction plans and better weather warn ing systems. Nine children eating in the East Coldenham cafeteria were killed in a Hail of Brick Concrete and Glass when a storm with 90-to 100-Mph winds slammed into the school. Fifteen students were injured. The 55-by-25-foot Wall built in 1959, was a masonry Structure surrounded by a series of Metal framed windows. An Engineer hired by the stale concluded the Wall was not designed to withstand winds of More than45 Mph although state building codes said it should have been designed to take winds of at least 75 Mph. If it was t for the windows surrounding the masonry Wall the Wall would Likely have tumbled Long ago said Peter Slocum a spokesman for both the state health department and the disaster commission. The windows increased the Wall s capacity to with stand winds up to 80 Mph. There were enough standards at the time to pro vide guidance to the professionals for an adequate de sign of the Wall said Richard Tomasetti an Engineer hired by the state to investigate the collapse. The Wall unfortunately was not adequately  the state s office of professional discipline is investigating the school s architect John Clark of Hyde Park said Thomas Sobol state education commission  was not in his office wednesday afternoon and was not available for comment. He has repeatedly refused to respond to reporters questions since the East Coldenham disaster. Howard Finkelstein a Newburgh lawyer said he s filed a notice of claim that he intends to sue Clark an the Valley Central school District on behalf of six of the dead children and 13 of the injured youngsters. He said the report buttresses the families Case. This is not an act of god Finkelstein said. God did not build the Wall. There arc human failings that took place for which someone is going to be response