FDA Adverse Event
Malfunction
Summary report: N
GOBED II MED/SURG BED
MDR report key: 3032117
·
Received March 6, 2013
Report
- Report Number
- 1831750-2013-90529
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 28, 2012
- Report Date
- February 29, 2012
- Manufacturer
- FLEXTRONICS EMS CANADA
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
LOAD CELL. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCALE WAS NOT ACCURATE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96547 | GOBED II MED/SURG BED | A/C HOSPITAL BED | FNL | FLEXTRONICS EMS CANADA | FL28C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |