MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-05 for CONVECTIVE PT WARMER TC3146 NA manufactured by Stryker Corp Dba Gaymar.
[17558912]
It was reported that the unit was overheating. No pt involvement or adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[17818605]
Service tech who evaluated the unit indicated that the unit was not repaired and was scrapped, but did not indicate whether the alleged event was confirmed through evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313850-2012-00006 |
| MDR Report Key | 2412172 |
| Report Source | 06 |
| Date Received | 2012-01-05 |
| Date of Report | 2011-12-07 |
| Date of Event | 2011-12-07 |
| Date Mfgr Received | 2011-12-07 |
| Device Manufacturer Date | 2007-08-15 |
| Date Added to Maude | 2012-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RENATA SILA |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693896689 |
| Manufacturer G1 | STRYKER CORP DBA GAYMAR |
| Manufacturer Street | 10 CENTRE DR. |
| Manufacturer City | ORCHARD PARK NY 14127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVECTIVE PT WARMER |
| Generic Name | PATIENT WARMER |
| Product Code | ILY |
| Date Received | 2012-01-05 |
| Model Number | TC3146 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP DBA GAYMAR |
| Manufacturer Address | ORCHARD PARK NY 14127 US 14127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-05 |