MalfunctionKRF

M SERIES

Received Dec 8, 2000

Report 1220908-2000-01343 · MDR key 308383

Device

Generic name

Defibrillator/pacemaker

Manufacturer

Zoll Medical Corporation

Model number

MSERIES

Catalog number

M SERIES

Lot number

Product problems

Device Displays Incorrect Message

Patient

Narrative

Description of Event or Problem

THE COMPLAINANT ALLEGED DURING A TRAINING SESSION BY A ZOLL SALES REP, THE DEVICE DISPLAYED "PACER FAULT 116", "PACER/DEFIB DISABLED", AND "DEFIB 72" MESSAGES. THE COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.