FDA Adverse Event
Malfunction
Summary report: N
POSEY PERSONAL ALARM
MDR report key: 1934016
·
Received December 1, 2010
Report
- Report Number
- 2020362-2010-00385
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Report Date
- November 2, 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED THE ALARM POWERED ON. THE ALARM SOUNDS CONTINUOUSLY WHEN THE MAGNET CLIP IS ATTACHED TO THE ALARM. THE ALARM WAS TESTED USING THE RETURNED MAGNET AS WELL AS TEST MAGNETS. THERE IS NO VISIBLE DAMAGE ON THE ALARM CASE. THE BATTERY CONNECTOR FITS LOOSE ON THE BATTERY. (B)(4).
Description of Event or Problem · 1
CUSTOMER CLAIMS THAT THE ALARM HAS POWER, BUT A CONTINOUS ALARM TONE WHEN THE MAGNET CLIP IS ATTACHED TO THE ALARM. THERE WAS NOT PT INCIDENT OR INJURY REPORTED. EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT THE BATTERY CONNECTOR FITS LOOSE ON THE BATTERY.
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 |