MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-15 for MOBIUS POWER * manufactured by Enovate Medical.
[5839500]
This is the nurse advocate charging system. Battery or battery charger sparked and caught fire. Battery was destroyed and unable to read serial number. Serial number of charger noted in report. Two charging stations damaged as a result. Like models of batteries lot #'s: 311801313021259 in adjacent charging station; 311801313050208 next to one catching fire. Other serial numbers not readable, model # mobius is 8116270. Size of battery 10. 95 volts, 26. 5 amp hours, 290. 18 watt hours. ======================manufacturer response for battery and battery charger, stinger medical mobius power (per site reporter). ======================field tech from ennovate medical on site. Field tech updated firmware of charging stations throughout hospital. Five charging stations total that were updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4823868 |
| MDR Report Key | 4823868 |
| Date Received | 2015-05-15 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-04-19 |
| Report Date | 2015-04-28 |
| Date Reported to FDA | 2015-05-15 |
| Date Reported to Mfgr | 2015-06-08 |
| Date Added to Maude | 2015-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | MOBIUS POWER |
| Generic Name | BATTERY CHARGER |
| Product Code | FCO |
| Date Received | 2015-05-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 18 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL |
| Manufacturer Address | 1152 PARK AVE. MURFREESBORO TN 37129 US 37129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-15 |