FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II
MDR report key: 2132359
·
Received June 13, 2011
Report
- Report Number
- 1831750-2011-05895
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 16, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: CRACKED HEAD LEFT SIDE RAIL PANEL. BROKEN HEAD LEFT TIMING LINK.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD LEFT SIDERAIL PANELS WERE CRACKED AND THE HEAD LEFT TIMING LINK WAS BROKEN. 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 |