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August 9, 1985

From the FDA: Data sought on artificial heart complications

JAMA. 1985;254(6):730. doi:10.1001/jama.1985.03360060028003

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Artificial Heart:  The FDA is asking Symbion Inc for a report on complications experienced by the last three artificial heart recipients at the Humana Hospital in Louisville. The Symbion (or Jarvik-7) heart is approved for use in a clinical study involving seven implantations, four of which have been carried out (JAMA [Medical News] 1985;253:2805-2813).

Apnea Monitor Alert:  One child has been electrocuted and two others have been burned as a result of unintentionally incorrect use of infant sleep apnea monitors in the home, FDA officials have learned. In all three cases, the leads intended to connect the infant electrodes to the monitor were unintentionally plugged into an electric power source, the FDA officials say, and device malfunction was not involved in any of the accidents. The FDA is sending letters to health professionals and organizations of parents (of infants using apnea monitors), warning of the potential danger and providing the