inforMED
MalfunctionFCP

UNIPOWER BATTERY

Received Dec 15, 2004 · Event occurred Dec 14, 2004

Report 562237 · MDR key 562237

Device

Generic name

Battery

Model number

B10544

Catalog number

B10544

Lot number

SO 0199135

Product problems

  • Battery failure
  • Melted
  • Overheating of Device
  • Replace
  • Device Issue

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

IN FOUR CASES THE FACILITY IS AWARE OF, REPLACEMENT BATTERIES FOR ZOLL PD-1200 DEFIBRILLATORS OVERHEATED AND FAILED. IN ONE CASE, THE HEAT MELTED THE WIRE INSULATION RESULTING IN A SHORT CIRCUIT OF THE BATTERY. BATTERIES FAILED IN LESS THAN TWO MONTHS FROM DATE OF THE INSTALLATION. HEAT FROM THE BATTERIES WAS SUFFICIENT TO MELT AND DEFORM THE BATTERY DOOR, REQUIRING REPLACEMENT. THE PROBLEM WAS DISCOVERED WHEN THE DEFIBRILLATORS FAILED THE DAILY FUNCTIONAL TEST. IN ADDITION TO THE DEFIBRILLATOR FAILING TO FUNCTION, THIS IS A POSSIBLE FIRE HAZARD.