FDA Adverse Event
Summary report: N
BIODEX GIMBAL ASSEMBLY
MDR report key: 2356568
·
Received November 29, 2011
Report
- Report Number
- 2356568
- Date Received
- November 29, 2011
- Date of Event
- November 16, 2011
- Report Date
- November 29, 2011
- Manufacturer
- BIODEX MEDICAL SYSTEMS, INC.
- Product Code
- BXB
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AT THE COMPLETION OF AN OUTPATIENT PHYSICAL THERAPY "BIODEX" TREATMENT, THE PHYSICAL THERAPY ASSISTANT (PTA) ATTEMPTED TO DISCONTINUE THE TREATMENT AND DISENGAGE THE PATIENT FROM THE MACHINE. THE MACHINE DID NOT SHUT OFF WHEN THE PTA ATTEMPTED TO SHUT IT OFF AND THE BIODEX ARM COMPRESSED DOWN ON THE PATIENT'S LEFT KNEE TEMPORARILY PINNING HER TO THE SEAT. NO APPARENT INJURY FROM INCIDENT. EMPLOYEE SUPERVISOR IDENTIFIED USER ERROR - NOT DEVICE MALFUNCTION - AS CAUSE OF INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIODEX GIMBAL ASSEMBLY | EXERCISER, POWERED | BXB | BIODEX MEDICAL SYSTEMS, INC. | 820-120 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | NO OTHER THERAPIES |