FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG ZOOM BED
MDR report key: 2221678
·
Received August 15, 2011
Report
- Report Number
- 1831750-2011-08644
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- July 18, 2011
- Report Date
- July 18, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: FOWLER, SIDE RAIL. CONCLUSION: REPLACEMENT PARTS HAVE BEEN ORDERED AND THE SERVICE TECHNICIAN WILL RETURN TO COMPLETE THE REPAIRS.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE FOWLER AND HEAD RIGHT SIDE RAIL HAVE BEEN SIGNIFICANTLY BENT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE 3 MED/SURG ZOOM BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002S3ZOOM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |