FDA Adverse Event
Malfunction
Summary report: N
ZOOM CRITICAL CARE BED
MDR report key: 2112515
·
Received May 25, 2011
Report
- Report Number
- 1831750-2011-05084
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 29, 2011
- Report Date
- April 29, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: DISPLAY HOUSING.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL PANEL IS CRACKED WITH POSSIBLE FLUID INTRUSION AND THE DISPLAY HOUSING IS DAMAGED WITH SHARP EDGES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOOM CRITICAL CARE BED | AC POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 2040 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |