Recipient: Encore Medical, LP
Product:muscle stimulators and ultrasound devices.
1. Failure to establish and maintain adequate procedures to identify actions(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, your firm failed to identify the action(s) needed to correct failures and prevent additional failures for the following:
a. During the period May 2006 through December 2007, your firm received 64 complaints of either shock and/or burns to patients caused by a transient over-voltage malfunction in the Stim boards used in your muscle stimulator EPR product line. You received 58 of these complaints after you identified the malfunction in January 2007. Although you developed software versions to detect the over-voltage and cause the device to shut down, you installed the revision only in muscle stimulators in stock or returned from the complainants. The software revisions were not installed in devices in distribution channels. In addition, you received 50 complaints of shock or burns caused by muscle stimulators in the market after you identified a correction in March 2007.
Your firm’s response is only partially adequate in addressing these violations. We acknowledge you have revised your written Corrective and Preventative Action (CAPA) procedures and provided written documentation for Corrective Action #1551. We acknowledge you recalled the muscle stimulators to install Software [redacted] in those devices. According to information your firm provided to FDA, the software revisions have been implemented to prevent a [redacted] from shorting. In addition, we acknowledge you have recalled your ultrasound devices from dist ribution channels because of high rates of diode failure.
Although your firm has begun to address FDA’s concerns, you have not provided verification and validation data to demonstrate the software revision will be effective over the life of the device. In your response to this warning letter, please provide the verification and validation plans and reports for Software [redacted]
FDA New Orleans District Office