FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2141399
·
Received June 1, 2011
Report
- Report Number
- 1831750-2011-05343
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 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
CRACKED HEAD LEFT SIDERAIL PANEL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD LEFT SIDERAIL PANEL WAS CRACKED, WITH FLUID INTRUSION, BUT IT WAS STILL OPERATIONAL, AND IT COULD BE RAISED, LOWERED, AND LOCKED IN THE UPRIGHT POSITION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
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 |