FDA Adverse Event
Malfunction
Summary report: N
S3 EX - 3005
MDR report key: 3032135
·
Received April 3, 2013
Report
- Report Number
- 0001831750-2013-02845
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 12, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BED LOST OF ALL MOTOR FUNCTIONS DUE TO MALFUNCTIONED CPU BOARD. 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 |
|---|---|---|---|---|---|---|---|
| 137331 | S3 EX - 3005 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |