FDA Adverse Event
Malfunction
Summary report: N
POSEY BED
MDR report key: 3770337
·
Received February 18, 2014
Report
- Report Number
- 2020362-2014-00040
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Report Date
- January 3, 2014
- Manufacturer
- J. T. POSEY CO.
- Product Code
- OYS
- PMA / PMN Number
- K113355
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: EVAL OF THE RETURNED PRODUCT FOUND THE ZIPPER SIDER BODY IS OPEN ON THE PT ACCESS WINDOW A. WINDOW SIDE B INSERT PIN IS MISSING ON THE ZIPPER. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED THE SLIDER AND PULL TAB IS DAMAGED ON THE CANOPY. CUSTOMER COULD NOT PROVIDE A DATE WHEN THIS ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101152 | POSEY BED | OYS | J. T. POSEY CO. | 8060 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |