FDA Adverse Event
Malfunction
Summary report: N
POSEY STAYSAFE BED
MDR report key: 2192547
·
Received June 30, 2011
Report
- Report Number
- 2020362-2011-00222
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Report Date
- May 24, 2011
- Manufacturer
- J. T. POSEY CO.
- Product Code
- FNL
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: EVALUATION OF THE RETURNED CANOPY SHOWS THAT THE PATIENT ACCESS PANEL SIDE B: WINDOW ZIPPER SLIDER BODY IS OPEN. NOTE: POSEY INSTRUCTIONS FOR USE WARNING INDICATES: NEVER USE THE BED IF A ZIPPER SLIDER IS BENT OPEN OR DAMAGED AND THE ZIPPER IS NOT SECURELY CLOSED. TEST THAT ALL OF THE ZIPPERS OPEN EASILY AND CLOSE SECURELY ALONG THE ENTIRE LENGTH OF THE ZIPPER. NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS PANEL OR THE ZIPPER SLIDER BY BENDING IT OPEN. MANUFACTURER REFERENCES FILE # (B)(4).
Description of Event or Problem · 1
CUSTOMER CLAIMS THAT THERE IS ZIPPER DAMAGE TO THE SIDE PANEL, BUT COULD NOT PROVIDE MORE INFORMATION. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSEY STAYSAFE BED | FNL | J. T. POSEY CO. | 8060 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |