FDA Adverse Event
Malfunction
Summary report: N
ZOOM CRITCAL CARE BED
MDR report key: 1933390
·
Received December 14, 2010
Report
- Report Number
- 1831750-2010-04845
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 17, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: ARM WELDMENT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT RIGHT ARM WELDMENT ASSEMBLY BROKE OFF. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOOM CRITCAL CARE BED | A/C POWERED HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIV. | 2040 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |