FDA Adverse Event
Malfunction
Summary report: N
HOOK & LOOP ALARM BELT
MDR report key: 2423423
·
Received January 13, 2012
Report
- Report Number
- 2020362-2012-00015
- Event Type
- Malfunction
- Date Received
- January 13, 2012
- Report Date
- December 16, 2011
- Manufacturer
- J. T. POSEY CO.
- Product Code
- KMI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL: RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THAT THE ALARM DID NOT SOUND WHEN THE SENSOR BELT WAS OPENED. THERE WAS NO PHYSICAL DAMAGES FOUND TO THE SENSOR BELT. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SENSOR WAS LEFT AT THEIR FACILITY IN WORKING CONDITION BY THE DISTRICT MANAGER. THE CUSTOMER CALLED THE DISTRICT MANAGER AFTER ONLY A FEW DAYS OF USE AND THE SENSOR WAS NOT WORKING. THEY REPORTED THAT WHEN THE SENSOR IS DETACHED THERE IS NO ALARM TONE. THE DISTRICT MANAGER TESTED THE SENSOR WITH ANOTHER WORKING ALARM BUT THE PROBLEM PERSISTS. THERE WAS NO PT INCIDENT OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOOK & LOOP ALARM BELT | KMI | J. T. POSEY CO. | 8372 | 061011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | POSEY SITTER ELITE: MODEL 8345, LOT# UNK |