inforMED
MalfunctionKRF

M SERIES

Received Dec 7, 2000 · Event occurred Nov 7, 2000

Report 1220908-2000-01324 · MDR key 308586

Device

Generic name

Defibrillator/pacemaker

Manufacturer

Zoll Medical Corp.

Model number

MSERIES

Catalog number

M SERIES

Lot number

NA

Product problems

  • Emergency stop button or switch failure

Patient

NA

Narrative

Description of Event or Problem

DURING THE INCOMING INSPECTION OF THE DEVICE, THE ZOLL TECHNICIAN OBSERVED THAT THE DEVICE'S EXTERNAL PADDLE CONTROL SWITCHES WERE NOT FUNCTIONING. THE COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.