FDA Adverse Event
Malfunction
Summary report: N
ZOOM CRITICAL CARE CED
MDR report key: 1421399
·
Received April 15, 2009
Report
- Report Number
- 1831750-2009-00210
- Event Type
- Malfunction
- Date Received
- April 15, 2009
- Date of Event
- March 16, 2009
- Report Date
- March 16, 2009
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOWLER CLUTCH.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BACKREST ON THIS BED WAS DRIFTING DOWN WHEN RAISED AND WOULD NOT STAY IN AN UPRIGHT POSITION. NO INJURY TO PATIENT OR USER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOOM CRITICAL CARE CED | A/C POWERED HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIVISION | 2040 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |