MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-29 for BIODEX GIMBAL ASSEMBLY 820-120 * manufactured by Biodex Medical Systems, Inc..
[2321082]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2356568 |
| MDR Report Key | 2356568 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-29 |
| Date of Event | 2011-11-16 |
| Report Date | 2011-11-29 |
| Date Reported to FDA | 2011-11-29 |
| Date Added to Maude | 2011-12-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODEX GIMBAL ASSEMBLY |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2011-11-29 |
| Model Number | 820-120 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODEX MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 20 RAMSAY ROAD SHIRLEY NY 11967070 US 11967 0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-29 |