FDA Adverse Event
Malfunction
Summary report: N
RAM MARK 2 PSS
MDR report key: 576503
·
Received February 14, 2005
Report
- Report Number
- 9617016-2005-00006
- Event Type
- Malfunction
- Date Received
- February 14, 2005
- Date of Event
- January 11, 2005
- Report Date
- February 14, 2005
- Manufacturer
- ELEKTA LIMITED
- Product Code
- INQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE LOWERING THE BED TO UNLOAD A PATIENT, THE TABLE TOP TILTED AND SLAMMED BACK DOWN. THE BED THEN MECHANICALLY DROPPED APPROXIMATELY 30CM. THE TABLE WAS IMMEDIATELY TAKEN OUT OF SERVICE PENDING SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAM MARK 2 PSS | TABLETOP | INQ | ELEKTA LIMITED | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |