FDA Adverse Event
Malfunction
Summary report: N
PATIENT ROOM ROCKER RECLINER
MDR report key: 3838012
·
Received May 29, 2014
Report
- Report Number
- 0001831750-2014-03022
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 6, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FRK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOT SECTION OF THE RECLINER DOES NOT ALWAYS LOCK. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316085 | PATIENT ROOM ROCKER RECLINER | CHAIR, EXAMINATION AND TREATMENT | FRK | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |