FDA Adverse Event
Malfunction
Summary report: N
3002 MASTER BOMS
MDR report key: 2925641
·
Received January 22, 2013
Report
- Report Number
- 0001831750-2013-00280
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- January 3, 2013
- Report Date
- January 3, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUPPLEMENTAL REPORTED SUBMITTED AS INVESTIGATION CONCLUDED THAT ALL SIDERAILS WERE ABLE TO BE LATCHED AND LOCKED IN ALL POSITIONS; THE INITIAL ISSUE OF THE SIDERAIL NOT LATCHING IN PLACE WAS REPORTED IN ERROR.
Additional Manufacturer Narrative · 1
(B)(4) - SIDERAIL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAIL WAS NOT LOCKING INTO PLACE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAIL WAS NOT LOCKING INTO PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31189 | 3002 MASTER BOMS | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |