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Mission Statement: To continuously inform and educate health care professionals on patient safety issues as related to medical devices, by providing a convenient mechanism in which to access current and emerging issues within the Federal domain. |
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Pulmonetic Systems Ventilators Recalled Pulmonetic Systems is recalling certain LTV series portable ventilators. The ventilators provide breathing support for adults and children in home care, hospitals and other institutions. A malfunction may prevent these ventilators from switching to internal battery operation when external power is inadequate, a problem that could cause the device to stop operating. The company is notifying customers and users about the malfunction and how to correct it. |
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Recall of Advanced Bionics Cochlear Implants Advanced Bionics is recalling all unimplanted CLARION and HiResolution cochlear implants because moisture in the internal circuitry of some of these devices may cause them to stop working. Signs of device failure may include intermittent functioning, sudden sensation of discomfort or pain, loud noise or complete loss of sound. FDA is not recommending removal or replacement of devices already implanted in patients.
Boston Scientific has sent a safety alert to health professionals about the use of Enteryx, a permanently implanted product used to treat patients with GERD symptoms. Enteryx is a liquid copolymer that's injected endoscopically into the muscle layer of the lower esophageal sphincter to help prevent acid reflux. The letter describes the death of a patient treated with Enteryx and reinforces the importance of closely following the product directions for use and proper injection technique. |
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Medtronic is recalling certain software application cards used in the company's Model 8840 N'Vision Clinician Programmers. These hand-held devices are used to program certain implantable devices, including the SynchroMed and SychroMed EL implantable infusion pumps. The recall is prompted by reports of data entry errors that have led to serious drug overdoses. The company is distributing replacement software to help reduce the risk of programming errors. Automatic External Defibrillator Cleared for OTC FDA recently granted marketing clearance for the first time for the over-the-counter sale of an automatic external defibrillator designed specifically for lay users. The HeartStart Home Defibrillator, manufactured by Philips Medical Systems, was already available with a prescription for use at home, but can now be purchased without a prescription. Safety Tips - Burning Beds Since 1993, FDA has learned of 95 fires involving electric hospital beds. Most of the fires were associated with such factors as overheated bed motors, arcing from ill-fitting plugs, damaged plugs, missing ground pins, fluid leaks that damaged the circuit boards, missing components in the wiring, poor maintenance, or failure to heed manufacturers’ warnings. |
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Updated October 5, 2004
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Center for Devices and Radiological Health / CDRH