MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-24 for TAYLOR WHARTON CRYOFREEZER 10K CRYOSTORAGE manufactured by Taylor Wharton.
[1283975]
A liquid nitrogen freezer controller failed to display the proper temperature and specimens were lost as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014928 |
| MDR Report Key | 1618840 |
| Date Received | 2010-02-24 |
| Date of Report | 2010-02-24 |
| Date of Event | 2010-01-22 |
| Date Added to Maude | 2010-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAYLOR WHARTON CRYOFREEZER |
| Generic Name | SPECIMEN FREEZER |
| Product Code | KSE |
| Date Received | 2010-02-24 |
| Model Number | 10K CRYOSTORAGE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAYLOR WHARTON |
| Manufacturer Address | THEODORE AL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-24 |