FDA Adverse Event
Malfunction
Summary report: N
POSEY KEEPSAFE DELUXE
MDR report key: 3040599
·
Received March 12, 2013
Report
- Report Number
- 2020362-2013-00103
- Event Type
- Malfunction
- Date Received
- March 12, 2013
- Report Date
- February 14, 2013
- Manufacturer
- J. T. POSEY CO.
- Product Code
- KMI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: EVAL OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE. THE ALARM POWERED ON AND PASSED ALL FUNCTIONAL TESTS. HOWEVER, THERE IS CORROSION FROM BATTERY LEAKAGE ON A FLAT BATTERY CONTACT. (B)(4).
Description of Event or Problem · 1
THE REPORTER STATED THAT THE POWER IS INTERMITTENT ON THE ALARM. THIS WAS DISCOVERED DURING A DEMONSTRATION TO THE HOSPITAL STAFF. THE REPORTER COULD NOT PROVIDE THE DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PATIENT CONTACT OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104500 | POSEY KEEPSAFE DELUXE | KMI | J. T. POSEY CO. | 8374 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |