FDA Adverse Event
Malfunction
Summary report: N
POSEY SITTER ELITE
MDR report key: 3904678
·
Received May 22, 2014
Report
- Report Number
- 2020362-2014-00192
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Report Date
- April 3, 2014
- Manufacturer
- J. T. POSEY COMPANY
- 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
RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT ISSUED. THE UNIT NURSE CALL RECEPTACLE OUTER HOUSING IS DAMAGED, BUT THE INTERNAL MECHANISM IS STILL INTACT. ALTHOUGH THE NURSE CALL RECEPTACLE IS DAMAGED, UNIT CAN STILL SECURE THE NURSE CALL CABLE. HOWEVER, THE RED LED AT THE NURSE CALL TEST FIXTURE TURNS ON AND OFF WHEN THE NURSE CALL CABLE IS MOVED. ALSO, A RATTLING SOUND IS HEARD COMING FROM INSIDE OF THE UNIT. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THE NURSE CALL RECEPTACLE ON THE ALARM IS DAMAGED. THE ISSUE WAS DISCOVERED DURING SETUP, BUT THE DATE IS UNKNOWN. NO PATIENT INCIDENT OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306890 | POSEY SITTER ELITE | KMI | J. T. POSEY COMPANY | 8345 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | NURSE CALL CABLE, MODEL 8282, LOT# UNKNOWN |