FDA Adverse Event
Malfunction
Summary report: N
ZOOM CRITICAL CARE BED
MDR report key: 1933261
·
Received December 2, 2010
Report
- Report Number
- 1831750-2010-04345
- Event Type
- Malfunction
- Date Received
- December 2, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: TIMING LINK.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE TIMING LINKS WERE REPLACED ON THE SIDE RAIL. IT IS UNK IF THERE WAS PT INVOLVEMENT NO ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOOM CRITICAL CARE BED | AC POWERED HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIVISION | 2040 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |