inforMED
MalfunctionILO

POLAR CARE KODIAK

Received Sep 16, 2022 · Event occurred Sep 3, 2022

Report 15437552 · MDR key 15437552

Device

Generic name

Pack, Hot Or Cold, Water Circulating

Manufacturer

Breg, Inc.

Model number

10601

Catalog number

10601

Product problems

  • Unintended Electrical Shock

Patient

19710 DA · Male

  • Electric Shock
  • Electric Shock

Narrative

Description of Event or Problem

PATIENT REPORTED TO HIS NURSE THAT HIS POLAR ICE MACHINE HAD SHOCKED HIS KNEE WHILE LYING IN BED. THIS OCCURRED 3 TIMES. THE NURSE REMOVED THE MACHINE FROM THE PATIENT AND REMOVED IT FROM SERVICE. THE INCIDENT WAS REPORTED TO THE DIRECTOR AND NURSE MANAGER. THE POLAR ICE MACHINE WAS REPLACED WITH A NEW MACHINE AND SLEEVE. BREG WAS CONTACTED ABOUT THIS INCIDENT.