MAUDE Adverse Event Report: BREG, INC. POLAR CARE KODIAK; PACK, HOT OR COLD, WATER CIRCULATING

Model Number 10601

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 09/03/2022

Event Type  malfunction  

Event Description

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.

• Brand Name: POLAR CARE KODIAK
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave e; carlsbad CA 92010
• MDR Report Key: 15437552
• MDR Text Key: 300042533
• Report Number: 15437552
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Event Location: Other
• Date Report to Manufacturer: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male
• Patient Race: White