Mike Barbella09.04.08
A rash of adverse incidents that occurred after Encore Medical had identified a problem with its muscle stimulators has resulted in a warning letter from the FDA.
Between May 2006 and last December, the firm received 64 complaints of patients being shocked or burned from an over-voltage malfunction in its muscle stimulator EPR product line. Of those complaints, 58 were made after the company had identified the malfunction, the letter said.
Although Encore had developed software to detect the over-voltage and shut down the device, it only installed the revision in stimulators that were in stock or that had been returned. The software revision was not installed in devices already distributed and in use.
In a similar incident with its Vectra Genisys product line, Encore became aware in 2005 of a malfunction in which diodes were failing on boards used to control ultrasound devices.
It modified the products in stock but did not replace the diodes in ultrasound devices in distribution, the letter says. As a result, a number of the devices had to be returned and replaced last year.
During the FDA inspection, the firm failed to provide the investigator with written documentation of its corrective and preventive action (CAPA) activities. In the warning letter, the FDA acknowledges Encore’s efforts to address the agency’s concerns. The company has revised its written CAPA procedures, provided documentation for a corrective action, recalled the muscle stimulators to install the software revision and recalled the ultrasound devices because of the high rate of diode failure.
SOURCE: FDANEWS
Between May 2006 and last December, the firm received 64 complaints of patients being shocked or burned from an over-voltage malfunction in its muscle stimulator EPR product line. Of those complaints, 58 were made after the company had identified the malfunction, the letter said.
Although Encore had developed software to detect the over-voltage and shut down the device, it only installed the revision in stimulators that were in stock or that had been returned. The software revision was not installed in devices already distributed and in use.
In a similar incident with its Vectra Genisys product line, Encore became aware in 2005 of a malfunction in which diodes were failing on boards used to control ultrasound devices.
It modified the products in stock but did not replace the diodes in ultrasound devices in distribution, the letter says. As a result, a number of the devices had to be returned and replaced last year.
During the FDA inspection, the firm failed to provide the investigator with written documentation of its corrective and preventive action (CAPA) activities. In the warning letter, the FDA acknowledges Encore’s efforts to address the agency’s concerns. The company has revised its written CAPA procedures, provided documentation for a corrective action, recalled the muscle stimulators to install the software revision and recalled the ultrasound devices because of the high rate of diode failure.
SOURCE: FDANEWS