MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for MOBIUS POWER 3.5 BATTERY PACK MOBIUSPOWER manufactured by Enovate Medical/ Stinger Medical.
[90768478]
Staff heard noises and hissing from wall mounted battery charger and visually saw smoke. Staff unplugged charger from outlet. Smoke alarm was triggered. Code red was called, security and engineering arrived, and while speaking to staff, a loud "explosion" was heard from the wall charger assembly, which contained one battery pack. Engineering grabbed the fire extinguisher and doused the charging assembly and battery. The fire department arrived and the battery and charger was removed. No injuries were reported. Per fda h0260 01: any actions taken by the manufacturer/facility: manufacturer was notified and will replace all 3. 0 series battery packs immediately. Charging stations in remote, rarely occupied areas have been removed. All 3. 0 series battery packs have been removed from service. All other batteries have been visually inspected by is dept. Fire extinguishers have been added beside all remaining charging stations. Event has been reported internally to (b)(6) and also fda medwatch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072979 |
| MDR Report Key | 6983180 |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-20 |
| Date Added to Maude | 2017-10-27 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | MOBIUS POWER 3.5 BATTERY PACK |
| Generic Name | MOBIUS POWER 3.5 BATTERY BOCK RECHARGEABLE |
| Product Code | FCO |
| Date Received | 2017-10-27 |
| Model Number | MOBIUSPOWER |
| Lot Number | 3ICP20/38/66-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL/ STINGER MEDICAL |
| Manufacturer Address | MURFREESBORO TN 37129 US 37129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-27 |