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Device malfunctions during routine maintenance are reportable -- FDA warning letter to Zoll.

This article was originally published in The Gray Sheet

Executive Summary

DEVICE MALFUNCTIONS DURING ROUTINE MAINTENANCE ARE REPORTABLE, FDA SAYS in a Nov. 21 warning letter to Zoll Medical. The warning letter, which follows an inspection conducted in September and October, cites two specific instances -- one in which a PD 1200 external defibrillator discharged when only one of the discharge buttons was pressed, and another in which a PD 1600 defibrillator shut down after three discharges with good batteries. Both events occurred during routine maintenance of the device and should have been reported because a reoccurrence "would be likely to cause or contribute to a death or serious injury," FDA says.
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