MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-28 for EPOCH XP manufactured by Axon Systems.
[1834580]
The technician placed the unit at the front of the head of the patient; the unit is manufactured without protection of overspray from suction irrigation so when the unit was sprayed, it shorted out some of the electrodes and caused first degree burns to the patient's ear, back and scalp. ======================health professional's impression======================did not realize the unit was not covered by the sterile draping; therefore, did not notice the burning to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1865027 |
| MDR Report Key | 1865027 |
| Date Received | 2010-09-28 |
| Date of Report | 2010-09-28 |
| Date of Event | 2010-05-11 |
| Report Date | 2010-09-28 |
| Date Reported to FDA | 2010-09-28 |
| Date Added to Maude | 2010-10-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPOCH XP |
| Generic Name | STIMULATOR, PHOTIC, EVOKED RESPONSE |
| Product Code | GWE |
| Date Received | 2010-09-28 |
| Returned To Mfg | 2010-05-24 |
| Model Number | EPOCH XP |
| Catalog Number | EPOCH XP |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AXON SYSTEMS |
| Manufacturer Address | 80-5 DAVIDS DRIVE HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-28 |