MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-05-09 for CHATTANOOGA INTELECT SHORTWARE 1600 manufactured by Djo, Llc.
[16434563]
Complaint received stating "the unit had become very hot under the monode and was sparking along with the smell of smoke. " product to be sent for review, but not yet received and/or reviewed. No pt involvement, no injury or impairment from this event. Without product review we are unable to confirm or deny if recurrence of the event would cause or contribute to a death or serious injury at this point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2013-00007 |
| MDR Report Key | 3114078 |
| Report Source | 99 |
| Date Received | 2013-05-09 |
| Date of Report | 2013-05-09 |
| Date of Event | 2013-04-12 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2013-07-17 |
| 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 ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA INTELECT SHORTWARE |
| Generic Name | INTELECT SHORTWAVE |
| Product Code | IMJ |
| Date Received | 2013-05-09 |
| Model Number | 1600 |
| Lot Number | T1379 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-09 |