FDA Adverse Event
Malfunction
Summary report: N
POSEY PERSONAL ALARM
MDR report key: 1913998
·
Received November 19, 2010
Report
- Report Number
- 2020362-2010-00359
- Event Type
- Malfunction
- Date Received
- November 19, 2010
- Report Date
- September 30, 2010
- Manufacturer
- J. T. POSEY CO.
- Product Code
- KMI
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): EVALUATION RESULTS (OTHER) - EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED THE ALARM POWERED ON. THE ALARM SOUNDS INTERMITTENTLY WHEN THE MAGNET IS ON THE MAGNET PLATE. THE UNIT BATTERY DOOR IS MISSING. (B)(4).
Description of Event or Problem · 1
CUSTOMER CLAIMS THAT WHEN THE PULL CORD IS ATTACHED TO THE ALARM, IT CONTINUES TO SOUND. THE MAGNET CONNECTION IS NOT LOOSE. THE BATTERIES WERE REPLACED AND THE BATTERY CONNECTION WIRES ARE INTACT. THE BATTERY DOOR IS MISSING. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED. EVALUATION FOR RETURNED SHOWS THE UNIT POWERED ON AND SOUNDS THE ALARM INTERMITTENTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSEY PERSONAL ALARM | KMI | J. T. POSEY CO. | 8202L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |