FDA Adverse Event
Malfunction
Summary report: N
HOSPITAL RECLINER CHAIR
MDR report key: 3823731
·
Received May 21, 2014
Report
- Report Number
- 0001831750-2014-03002
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- April 25, 2014
- Report Date
- April 25, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FRK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO OF THE BRAKES WERE NOT HOLDING DUE TO WORN CASTERS. 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 |
|---|---|---|---|---|---|---|---|
| 302262 | HOSPITAL RECLINER CHAIR | CHAIR, EXAMINATION AND TREATMENT | FRK | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |