FDA Adverse Event
Malfunction
Summary report: N
OR TABLE
MDR report key: 2231676
·
Received August 29, 2011
Report
- Report Number
- 2231676
- Event Type
- Malfunction
- Date Received
- August 29, 2011
- Date of Event
- August 25, 2011
- Report Date
- August 29, 2011
- Manufacturer
- SKYTRON
- Product Code
- GDC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE OR TABLE WAS CHECKED PRIOR TO BRINGING THE PATIENT INTO THE ROOM AND IT LOCKED. WHEN THE ROOM WAS CLEANED AND THE PATIENT WAS ON THE OR TABLE, THE BED WAS UNLOCKED AND TURNED FOR POSITIONING. WHEN THE STAFF ATTEMPTED TO RELOCK THE OR TABLE AFTER RE-POSITIONING, IT WOULD NOT LOCK.====================== MANUFACTURER RESPONSE FOR TABLE, SURGICAL, OR TABLE (PER SITE REPORTER)======================ASSISTED OUR CLINICAL ENGINEERING DEPARTMENT IN REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OR TABLE | TABLE, SURGICAL | GDC | SKYTRON | 6500 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |