FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG MED
MDR report key: 2191616
·
Received July 1, 2011
Report
- Report Number
- 1831750-2011-06656
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 7, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: DAMAGED SIDERAILS PANELS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE MANUAL CPR RELEASE HORSESHOE IS MISSING, AND THE LEFT HEAD-END PANELS WERE DAMAGED. THERE WAS PT INVOLVEMENT. HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG MED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |