FDA Adverse Event
Malfunction
Summary report: N
POSEY SITTER II
MDR report key: 1881503
·
Received October 19, 2010
Report
- Report Number
- 2020362-2010-00286
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Report Date
- September 23, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. (B)(4).
Description of Event or Problem · 1
CUSTOMER CLAIMS THAT THE ALARM DOES HAVE POWER. WHEN THE ALARM IS USED WITH A SENSOR PAD AND WEIGHT IS REMOVED FROM THE PAD, THE ALARM SOUNDS WITH SHORT STATIC AND IMMEDIATELY POWERS OFF. THE BATTERIES WERE REPLACED WITH THE SAME TYPE. THERE IS NO CORROSION OR LOOSE WIRES. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM UNIT. THERE WAS NO PT INJURY OR INCIDENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSEY SITTER II | KMI | J. T. POSEY CO. | 8281 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | SENSOR PAD: MODEL PN 8307, LOT # UNK |