FDA Adverse Event
Malfunction
Summary report: N
POSEY SITTER ELITE
MDR report key: 3904692
·
Received May 22, 2014
Report
- Report Number
- 2020362-2014-00201
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Report Date
- April 23, 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE THE NURSE CALL FEATURE DOES NOT TURN ON WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. ADDITIONALLY, THE MODE FEATURE DOES NOT SWITCH BETWEEN VOICE ONLY AND MUTE. THE UNIT PASSED ALL OTHER FUNCTIONAL TESTING. NO PHYSICAL DAMAGE TO THE UNIT WAS OBSERVED. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THE ALARM DOES NOT SOUND AT THE NURSE CALL STATION. THE NURSE CALL CABLE WAS TESTED WITH A KNOWN WORKING ALARM AND THE NURSE CALL CABLE FUNCTIONS PROPERLY. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306504 | POSEY SITTER ELITE | KMI | J. T. POSEY COMPANY | 8345 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NURSE CALL CABLE, MODEL 8282, LOT # UNKNOWN |