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

Model Number PC CUBE W/ M/U XL WO

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Event Description

The device leaked water all over the patient and the bed.The device began leaking after it was already in use.Staff did not have any difficulty setting up the device (connecting the tubing).Staff indicated the moisture was not from condensation, it was a leak.This is the third time this type of problem has occurred within the last year.The leak was over a surgical site but no additional intervention was needed for the patient.

• Brand Name: BREG
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave. east; carlsbad CA 92010
• MDR Report Key: 7663485
• MDR Text Key: 113184125
• Report Number: 7663485
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00672736017739
• UDI-Public: (01)00672736017739
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PC CUBE W/ M/U XL WO
• Device Catalogue Number: 10710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1