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

Model Number	POLAR CARE CUBE
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Our hospital has noticed a trend in ice/water containers leaking during post-surgical orthopedic surgery.No harm to any patients but over the past month or so we've see approximately 9 ice coolers and/ or their connected pads leaking.We have been sending the ice boxes and pads back to the manufacturer for replacements and we came to understand the consistent need to replace so many we felt it time to look at the issue.Most ice cooler boxes and the related connecting pads are not fully identified as far as lot numbers; however, we felt we needed to move forward with at least 1 lot number of a known-device.Again, no patient harm but just aspect of the devices consistently leaking.

• Brand Name: BREG
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker avenue east; carlsbad CA 92010
• MDR Report Key: 8499835
• Report Number: 8499835
• Device Sequence Number: 2798048
• Product Code: ILO
• UDI-Device Identifier: 00672736017647
• UDI-Public: (01)00672736017647
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/21/2019
• Report Date (Section F): 02/21/2019

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: Lay User/Patient
• Device Model Number: POLAR CARE CUBE
• Device Catalogue Number: 10701
• Device Lot Number: 292368283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2019
• 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: 02/21/2019