FDA Adverse Event
Malfunction
Summary report: N
THERMOPHORE ARTHRITIS PAD
MDR report key: 2220177
·
Received August 15, 2011
Report
- Report Number
- 1811605-2011-00097
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 16, 2011
- Manufacturer
- BATTLE CREEK EQUIPMENT COMPANY
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THE SWITCH FAILED. UPON EXAMINATION, WE DISCOVERED THAT A PCB COMPONENT APPEARS TO HAVE SHORTED, CAUSING OTHER COMPONENT TO FAIL. THE FLAME-RETARDANT SWITCH HOUSING CONTAINED THE EVENT PROPERLY, BUT WAS DEFORMED IN THE PROCESS. AT OUR REQUEST, THE MFR OF THE SWITCH HAS ENACTED SEVERAL CAPA PROJECTS TO IMPROVED THE QUALITY OF THE SWITCH. THE OCCURRENCE OF BOARD COMPONENT FAILURES HAS DROPPED SIGNIFICANTLY IN THE PAST 12 MONTHS.
Description of Event or Problem · 1
IT WAS REPORTED THE SWITCH FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOPHORE ARTHRITIS PAD | ELECTRIC MOIST HEAT PACK | IRT | BATTLE CREEK EQUIPMENT COMPANY | 155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |