FDA Adverse Event
Malfunction
Summary report: N
POSEY STAYSAFE BED
MDR report key: 1945301
·
Received December 22, 2010
Report
- Report Number
- 2020362-2010-00409
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Report Date
- October 19, 2010
- 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
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) ZIPPER NOT FUNCTIONING PROPERLY. EVALUATION: RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT ON THE LEFT SIDE MAIN ACCESS WINDOW THE ZIPPER SLIDER BODY IS OPEN. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: NEVER TRY TO RIP A PANEL OPEN AS THIS MAY DAMAGE THE ACCESS PANEL OR THE ZIPPER SLIDER. MANUFACTURER REFERENCES FILE #: (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CLAIMS THAT THE ZIPPER ON THE SIDE PANEL IS NOT FUNCTIONING PROPERLY BUT COULD NOT SPECIFY THE EXACT PRODUCT ISSUE OR LOCATION. THERE WAS NO PT INCIDENT OR INJURY REPORTED. INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE LEFT SIDE MAIN ACCESS WINDOW ZIPPER SLIDER BODY IS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POSEY STAYSAFE BED | FNL | J. T. POSEY CO. | 8070 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |