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

Model Number PC CUBE W/ M/U XL WO

Device Problem Leak/Splash (1354)

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

Event Date 02/16/2018

Event Type  malfunction  

Event Description

The tubing to the patient end of the device leaked all over the patient's dressing and bed.Manufacturer response for pack, hot or cold, water circulating, breg (per site reporter): none yet.

• Brand Name: BREG PC CUBE
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): BREG, INC.; 2885 loker ave east; carlsbad CA 92010
• MDR Report Key: 7295664
• MDR Text Key: 100939963
• Report Number: 7295664
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00672736017739
• UDI-Public: (01)00672736017739
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES