MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for CHATTANOOGA MODEL E-2 manufactured by Djo Llc.
[145760899]
An employee was sitting at her computer about 5 feet from the equipment (hydro collator) when she heard/saw a spark and saw flames and smoke coming from the back of the equipment. She saw what was going on and was on her way to get the fire extinguisher, but noticed the fire was going out quickly. Eventually the staff unplugged the power cord from the unit and the wall. Minor damage to the counter top. Potentially major damage to the equipment. Unclear whether this was a building electrical issue or an equipment malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8631079 |
| MDR Report Key | 8631079 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-04-30 |
| Report Date | 2019-05-13 |
| Date Reported to FDA | 2019-05-13 |
| Date Reported to Mfgr | 2019-05-22 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | HYDROCOLLATOR |
| Product Code | IRQ |
| Date Received | 2019-05-22 |
| Model Number | MODEL E-2 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-05-22 |