MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-29 for REVCO ULTIMA SERIES * manufactured by Thermo Fisher Scientific (asheville), Llc.
[4914529]
Bone freezer not maintaining proper temperature. Service company came out to evaluate problem, gave high dollar estimate to rebuild compressors in freezer. Biomed contacted manufacturer who is going to rebuild the compressors at a much lower cost. This unit is 6. 5 yrs old and this has been an ongoing problem as well as with other issues. Service company comes out to evaluate issues with history of replacing parts with no definitive problem identified or solved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4146566 |
| MDR Report Key | 4146566 |
| Date Received | 2014-09-29 |
| Date of Report | 2014-09-29 |
| Date of Event | 2014-09-16 |
| Report Date | 2014-09-29 |
| Date Reported to FDA | 2014-09-29 |
| Date Reported to Mfgr | 2014-10-07 |
| Date Added to Maude | 2014-10-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVCO ULTIMA SERIES |
| Generic Name | FREEZER |
| Product Code | JRM |
| Date Received | 2014-09-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMO FISHER SCIENTIFIC (ASHEVILLE), LLC |
| Manufacturer Address | 275 AIKEN ROAD ASHEVILLE NC 28804 US 28804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-29 |