FDA Adverse Event
Malfunction
Summary report: N
WARMTOUCH COMPACT WARMING UNIT
MDR report key: 1161387
·
Received September 12, 2008
Report
- Report Number
- 2936999-2008-00421
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 15, 2008
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- DWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE WARMTOUCH FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE WARMTOUCH 5200 AND 5300 PATIENT WARMER HAVE BEEN DISCONTINUED, AND ARE BEING REPLACED WITH A NEW DESIGNED WARMTOUCH PATIENT WARMER. ACTIVE CUSTOMERS HAVE BEEN NOTIFIED OF THE AVAILABILITY OF THE NEW 5300A MODEL WHICH ADDRESSES THE POTENTIAL FAILURE MODE.
Description of Event or Problem · 1
THE CALLER STATED THE WARMTOUCH UNIT OVERHEATED AND BEGAN TO SMOKE. THE CALLER DID NOT KNOW THE TEMPERATURE SETTING OF THE UNIT DURING THE EVENT, HOW LONG IT HAD BEEN LEFT ON, OR WHEN PREVENTATIVE MAINTENANCE OR FILTER REPLACEMENT WAS DONE. THERE WAS NO PATIENT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WARMTOUCH COMPACT WARMING UNIT | CONVECTIVE AIR WARMER | DWJ | COVIDIEN/FORMERLY TYCO HEALTHCARE | 5300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |