FDA tracks Park gamma camera failure

The perils of buying expensive capital medical equipment from companies in poor financial health were brought into focus last month after the Food and Drug Administration announced the failure of a gamma camera manufactured by Park Medical Systems, which went out of business last year.

According to the FDA, a stainless steel plate from a harmonic drive motor on an Isocam II camera failed, causing an arm of the dual-head system to fall into the gantry housing of the device. No collimator was on the camera at the time and no patient or operator was injured.

Adverse events such as the Isocam II failure are usually reported to the device manufacturer, but since Park filed for bankruptcy last year, the FDA is advising owners of Park systems to report any adverse events due to device malfunction to the agency itself. The FDA is also asking owners of Park systems to notify the agency so it can forward new information to Park users. The FDA's contact on the Park issue is Paula Simenauer, who can be reached by fax at 301/594-2968 or by e-mail at pzs@cdrh.fda.gov.

Park filed for bankruptcy in July after struggling to stay afloat for much of 1997 (SCAN 8/6/97), and the status of much of the company's installed base regarding service and maintenance issues is unknown. At least one Park facility, however, Cedars-Sinai Medical Center in Los Angeles, is using the multivendor service operations of ADAC Laboratories to maintain its system. Cedars-Sinai signed on with ADAC six months ago, according to a hospital spokesperson.