FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2150245
·
Received June 10, 2011
Report
- Report Number
- 1831750-2011-05830
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 13, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: DAMAGED MOTION INTERRUPT PAN AND FOOTBOARD MODULES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOTBOARD CONTROL MODULES AND THE MOTION INTERRUPT PAN WERE DAMAGED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3002 SECURE II | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |