MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for BREG PC CUBE W/ M/U XL WO 10710 manufactured by Breg, Inc..
[113184125]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7663485 |
| MDR Report Key | 7663485 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-18 |
| Report Date | 2018-06-13 |
| Date Reported to FDA | 2018-06-13 |
| Date Reported to Mfgr | 2018-07-03 |
| Date Added to Maude | 2018-07-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREG |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | ILO |
| Date Received | 2018-07-05 |
| Model Number | PC CUBE W/ M/U XL WO |
| Catalog Number | 10710 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREG, INC. |
| Manufacturer Address | 2885 LOKER AVE. EAST CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |