MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-06 for 940-200 manufactured by Biodex Medical Systems, Inc..
[1280228]
Event desc: the pt was in out-patient rehab completing an exercise on a cable column. The cable support ring that covered the link between the cable and the pt handle broke and exposed a metal edge. The pt received a skin tear from the exposed barb. The area was cleaned with alcohol. Bandaid and pressure applied. Device usage problem.
Patient Sequence No: 1, Text Type: D, B5
[8507353]
This device advises the weekly inspection of weight stack cable for wear or damage. Initial incident reported the cable end termination cover deteriorated. We out-lined the inspection process in our instruction manual. The user should adhere to the manufacturer's requirements. The weight stack cable did not break. No pictures were provided to biodex. Talking to biomed the plastic cover on the cable appears to have deteriorated exposing the metal loop support ring and the metal end of the loop ring caused an abrasion to the pt. Based on our conversation with the hospital biomed department, they will replace the original deteriorated cable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431314-2009-00001 |
| MDR Report Key | 1603398 |
| Report Source | 06 |
| Date Received | 2009-11-06 |
| Date of Report | 2009-10-06 |
| Date of Event | 2009-09-30 |
| Report Date | 2009-10-01 |
| Date Reported to FDA | 2009-10-01 |
| Date Mfgr Received | 2009-09-30 |
| Device Manufacturer Date | 1995-02-01 |
| Date Added to Maude | 2011-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 20 RAMSAY RD. |
| Manufacturer City | SHIRLEY NY 11967 |
| Manufacturer Country | US |
| Manufacturer Postal | 11967 |
| Manufacturer Phone | 6319249000 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SYSTEM, ISOKINETIC TESTING AND EVALUATION |
| Product Code | IKK |
| Date Received | 2009-11-06 |
| Model Number | 940-200 |
| ID Number | CABLE COLUMN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODEX MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 20 RAMSAY RD. SHIRLEY NY 11967 US 11967 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-06 |