FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II MED/SURG BED
MDR report key: 2841629
·
Received October 24, 2012
Report
- Report Number
- 1831750-2012-11188
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- September 27, 2012
- Report Date
- September 27, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
HEAD AND FOOTEND CAM LINK ASSEMBLIES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING PROPERLY DUE TO HEAD AND FOOTEND BOLTS WERE PULLING OUT OF THE BRAKE CAMS. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3002 SECURE II MED/SURG BED | SECURE II MED/SURG BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |