FDA Adverse Event
Malfunction
Summary report: N
THERMOPHORE MAXHEAT PAD
MDR report key: 2232976
·
Received July 22, 2011
Report
- Report Number
- 1811605-2011-00084
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 1, 2011
- Report Date
- July 5, 2011
- Manufacturer
- BATTLE CREEK EQUIPMENT COMPANY
- 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 SWITCH REMAINED ACTIVATED AT ALL TIMES WHEN CONNECTED TO A POWER SOURCE. OUR EXAMINATION CONFIRMED THIS REPORT, BUT WE WERE UNABLE TO DETERMINE THE CAUSE OF THE MALFUNCTION. WE HAVE RETURNED THE UNIT TO THE SWITCH MANUFACTURER FOR FURTHER EXAMINATION AND TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SWITCH REMAINED ACTIVATED AT ALL TIMES WHEN CONNECTED TO A POWER SOURCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOPHORE MAXHEAT PAD | ELECTRIC MOIST HEAT PACK | IRT | BATTLE CREEK EQUIPMENT COMPANY | 155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |