FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE II MED/SURG BED
MDR report key: 2971979
·
Received January 21, 2013
Report
- Report Number
- 1831750-2013-90512
- Event Type
- Malfunction
- Date Received
- January 21, 2013
- Date of Event
- December 21, 2012
- Report Date
- December 21, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
MOTION INTERRUPT PAN. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE MOTION INTERRUPT PAN WAS CRACKED BY THE MOUNTING SCREW HOLES. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29002 | 3002 SECURE II MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |