MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2010-02-11 for OPTIFLEX III 2090 manufactured by Chattanooga Group.
[1434263]
Complainant reports that device smoked and shorted out.
Patient Sequence No: 1, Text Type: D, B5
[8442487]
Per chattanooga group engineering eval of device: "receptacle pulled out of chassis shorting to out. Damaged receptacle replaced and glued in. Replaced power supply as a precaution and hi pot test preformed. Unit passed test preformed after parts replaced. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00182 |
| MDR Report Key | 1626321 |
| Report Source | 04,05,06 |
| Date Received | 2010-02-11 |
| Date of Report | 2009-11-11 |
| Date of Event | 2009-11-11 |
| Date Mfgr Received | 2009-11-11 |
| Date Added to Maude | 2012-05-18 |
| 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 | 0 |
| 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 | 4238707281 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLEX III |
| Product Code | BXB |
| Date Received | 2010-02-11 |
| Returned To Mfg | 2010-01-06 |
| Model Number | 2090 |
| Catalog Number | 2090 |
| Device Availability | Y |
| 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 | 2010-02-11 |