FDA Adverse Event
Malfunction
Summary report: N
POSEY KEEPSAFE FALL MONITOR
MDR report key: 1821291
·
Received August 26, 2010
Report
- Report Number
- 2020362-2010-00195
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Report Date
- July 9, 2010
- Manufacturer
- DONGGUAN POSET MEDICAL DEVICE LTD.
- 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): EVAL: RESULTS - EVAL OF THE RETURNED PRODUCT FOUND THAT THERE IS NO ALARM TONE WHEN PRESSURE IS OFF OF THE PAD. THE TONE SELECTOR DOES NOT WORK AND THE FAIL SAFE DOES NOT WORK. THE PINS IN THE RJ11 RECEPTACLE ARE BENT. THE BLACK BATTERY WIRE INSULATION IS DAMAGE BUT THE WIRES ARE STILL INTACT. THE BATTERY DOOR IS MISSING. THERE IS A STRONG URINE SMELL COMING FROM THE ALARM. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE ALARM HAS POWER BUT NO ALARM TONE WHEN PRESSURE IS OFF OF THE PAD. THERE WAS NO VISIBLE DAMAGE REPORTED. THIS WAS DISCOVERED DURING SET UP AND THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSEY KEEPSAFE FALL MONITOR | KMI | DONGGUAN POSET MEDICAL DEVICE LTD. | 8350 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |