MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-28 for OPTIFLEX III CPM 2090 manufactured by Chattanooga Group.
[19929191]
Customer ((b) (6) medical center) complained that power cord plug-in on unit, pulled out of unit and caught on fire. The unit was not in use at the time of discovery. No injury occurred and no patient was involved. The person who pulled out the cord was also not harmed. Device has malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: D, B5
[20098477]
Unit failed initial electrical safety testing. The iec connector was pulled out of its receptacle with burn marks on it. One pin was melted off making the connector unusable. A loose connection was found that could have been a contributing factor. The units grounding tested good with only. 5 ohms from frame to pin and. 8 ohms resistance to the end of the plug. Replaced the iec connector before continuing to test the unit and the unit passed wonderfully. Conclusion: the unit's iec connector failed to remain intact, and a connection was loose which is the cause of the fire. I believe the connection pulled loose and made direct contact with the frame of the unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2010-00009 |
| MDR Report Key | 1743176 |
| Report Source | 05 |
| Date Received | 2010-06-28 |
| Date of Report | 2010-06-28 |
| Date of Event | 2010-03-23 |
| Date Mfgr Received | 2010-03-23 |
| Date Added to Maude | 2010-07-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | CHATTANOOGA GROUP |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLEX III CPM |
| Product Code | BXB |
| Date Received | 2010-06-28 |
| Returned To Mfg | 2010-04-09 |
| Model Number | 2090 |
| Catalog Number | 2090 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-28 |