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

Model Number	PC CUBE W/ M/U XL WO
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave. east; carlsbad CA 92010
• MDR Report Key: 7663485
• Report Number: 7663485
• Device Sequence Number: 1758530
• Product Code: ILO
• UDI-Device Identifier: 00672736017739
• UDI-Public: (01)00672736017739
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/13/2018
• Report Date (Section F): 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
• Operator of Device: No Information
• Device Model Number: PC CUBE W/ M/U XL WO
• Device Catalogue Number: 10710
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/13/2018