FDA Adverse Event
Malfunction
Summary report: N
ZOOM CRITICAL CARE BED
MDR report key: 2141360
·
Received June 1, 2011
Report
- Report Number
- 1831750-2011-05340
- 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
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THE PARTS NEEDED FOR THIS REPAIR HAVE BEEN ORDERED. THE SVC TECH WILL RETURN TO COMPLETE THE REPAIR ONCE THE PARTS HAVE BEEN RECEIVED. MFR'S INVESTIGATION IS STILL ONGOING; IF ADD'L INFO IS RECEIVED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE DISPLAY/CPU BOARD WAS NOT FUNCTIONING TO SPEC. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOOM CRITICAL CARE BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 2040 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |