MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-19 for OPTIFLEX III CPM 2090 manufactured by Chattanooga Group.
[1166000]
Patient shocked when using continuous passive motion device for physical therapy treatment on knee.
Patient Sequence No: 1, Text Type: D, B5
[8433479]
The device was evaluated by our engineering department. Engineering found damage to power cord. Power cord was cut in several places. Ground wire disconnected. Power cord was replaced, wire was reconnected, device performed to normal specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00156 |
| MDR Report Key | 1406215 |
| Report Source | 05 |
| Date Received | 2009-06-19 |
| Date of Report | 2009-05-22 |
| Date Mfgr Received | 2009-05-22 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2009-06-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLEX III CPM |
| Product Code | BXB |
| Date Received | 2009-06-19 |
| Returned To Mfg | 2009-06-17 |
| Model Number | 2090 |
| Catalog Number | 2090 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-19 |