FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2000259
·
Received February 18, 2011
Report
- Report Number
- 1831750-2011-01629
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Date of Event
- October 28, 2010
- Report Date
- October 28, 2010
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, IT IS UNKNOWN WHAT POSITION THE BED WAS IN AT THE TIME OF THE COMPONENT FAILURE. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE CPU BOARD NEEDED TO BE REPLACED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |