FDA Adverse Event
Malfunction
Summary report: N
POSEY SITTER II
MDR report key: 1893954
·
Received November 3, 2010
Report
- Report Number
- 2020362-2010-00296
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Report Date
- July 22, 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
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) (CUSTOMER DID NOT SPECIFY THE NATURE OF THE COMPLAINT). RESULTS - EVALUATION FOR THE RETURNED PRODUCT SHOWS THE ALARM TONE HAS STATIC NOISE WHEN ITS CHANGED AND WHEN PRESSURE IS APPLIED TO THE SENSOR PAD. THE ALARM PCB SHOWS CORROSION AND BATTERY LEAKAGE. THE UNIT BATTERY DOOR IS BROKEN AND SLIDES OUT FROM THE ALARM. POSEY INSTRUCTIONS RECOMMENDS: THE USE OF ALKALINE BATTERIES IN POSEY FALL ALARMS. DO NOT MIX OLD AND NEW BATTERIES, OR MIX DIFFERENT TYPES OF BATTERIES. THIS CAN CAUSE CORROSION AND LEAKAGE TO THE ALARM UNIT. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER DID NOT PROVIDE THE NATURE OF THE COMPLAINT. THERE WAS NO PATIENT INJURY OR INCIDENT REPORTED. EVALUATION FOR THE RETURNED PRODUCT SHOWS BATTERY LEAKAGE AND CORROSION.
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 |