FDA Adverse Event
Malfunction
Summary report: N
POSEY SITTER ELITE
MDR report key: 3994149
·
Received July 24, 2014
Report
- Report Number
- 2020362-2014-00249
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Report Date
- June 23, 2014
- 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
- ID, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS SUBMITTED BASED ON THE CUSTOMERS REPORTED ISSUE STATEMENT. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED WHEN THE NURSE CALL OPTION IS IN USE IT DOES NOT SEND A SIGNAL TO THE NURSE CALL STATION. ADDITIONALLY, THE HOLD BUTTON APPEARS TO BE JAMMED. THE DATE OF THE EVENT IS UNK. NO PT INCIDENT OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433834 | POSEY SITTER ELITE | KMI | J. T. POSEY CO. | 8345 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NURSE CALL CABLE: MODEL 8282 LOT # UNK |