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 CRM 2090 manufactured by Chattanooga Group.
[17059596]
Customer ((b)(6) regional medical center) complained that power cord plug-in on unit pulled out of unit. The unit was not in use at the time of discovery. No injury occurred and no patient was involved. 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
[17239959]
Unit failed initial electrical safety testing. The iec connector was pulled out of its receptacle. It appeared to have been physically pulled out of the enclosure. The units grounding tested good with only. 5 ohms from frame to pin. No power cord was supplied so i was unable to test. Replaced the iec connector before continuing to test the unit and the unit passed. While performing the pre burn-in testing it was discovered that the motor had failed. It will need to be replaced before the unit will be operational. Conclusion: the units iec connector failed to remain intact which is likely the cause of the motor failure. It looked to have been forcefully pulled out. If the ground connector made contact with one of the power wires it would present a fire hazard. It will need to be replaced before returning to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2010-00010 |
| MDR Report Key | 1743186 |
| Report Source | 05 |
| Date Received | 2010-06-28 |
| Date of Report | 2010-06-28 |
| Date of Event | 2010-04-20 |
| Date Mfgr Received | 2010-04-20 |
| Device Manufacturer Date | 2009-02-26 |
| Date Added to Maude | 2011-08-16 |
| 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 CRM |
| Product Code | BXB |
| Date Received | 2010-06-28 |
| Returned To Mfg | 2010-05-14 |
| 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 |