FDA Adverse Event
Malfunction
Summary report: N
POSEY SITTER II WIRELESS NURSE CALL TRANSMITTER
MDR report key: 1813256
·
Received August 18, 2010
Report
- Report Number
- 2020362-2010-00169
- Event Type
- Malfunction
- Date Received
- August 18, 2010
- Report Date
- April 16, 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
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - PAGER DISPLAYS OUT OF RANGE: EVALUATION RESULTS: EVALUATION FOR THE RETURNED PRODUCTS SHOWS WHEN TESTED THE PRODUCTS POWERED ON, BUT THE ALARM SOUNDS INTERMITTENTLY. THE RETURNED PRODUCTS ARE OBSOLETE. (B)(4).
Description of Event or Problem · 1
CUSTOMER CLAIMS THAT THE PAGER ALWAYS DISPLAY OUT OF RANGE AND DOESN'T MATTER THE DISTANCE. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED. EVALUATION FOR THE RETURNED PRODUCT SHOWS WHEN TESTED THE UNIT POWERED ON AND ALARMS INTERMITTENTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSEY SITTER II WIRELESS NURSE CALL TRANSMITTER | KMI | J. T. POSEY CO. | 8293 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | WIRELESS NURSE CALL PAGER: PN 829441, (B)(4) |