FDA Adverse Event
Malfunction
Summary report: N
THERMOPHORE ARTHRITIS PAD
MDR report key: 2043087
·
Received March 15, 2011
Report
- Report Number
- 1811605-2011-00023
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 9, 2011
- Manufacturer
- BATTLE CREEK EQUIPMENT CO.
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE DEAD-MAN SWITCH REMAINED "ON" WHEN THE HANDLE WAS RELEASED. OUR INVESTIGATION REVEALED THAT THE SWITCH APPEARS TO HAVE BEEN ALTERED BY THE CUSTOMER. THE SWITCH HANDLE IS BROKEN AND THE RETURN SPRING IS MISSING, WHICH PREVENTS THE MOMENTARY SWITCH FROM RELEASING. THIS FAILURE IS CONSISTENT WITH THE SWITCH BEING STUCK IN A RECLINER OR OTHER MECHANISM. WE CONCLUDED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE AND UNAUTHORIZED MODIFICATION OF THE SWITCH ON THE PART OF THE CONSUMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT SWITCH EMITTED SPARKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOPHORE ARTHRITIS PAD | ELECTRIC MOIST HEAT PACK | IRT | BATTLE CREEK EQUIPMENT CO. | 055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |