MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-12 for MOBIUS POWER manufactured by Enovate Medical Mobius Power.
[64766116]
At approx 10:54 am on (b)(6) 2017, a popping sound was heard coming from a mobile workstation battery charger. The unit then started to produce a large amount of smoke and flame. Three batteries were included with one being completely destroyed. The fire was suppressed. The fire caused a great amount of smoke resulting in evacuation of the pt care unit to a different floor. Two visitors and four staff members were treated for smoke inhalation. No pts were involved or harmed. The battery was being charged at the time. The mfr is replacing all batteries and chargers with a newer model. The organization is performing a risk assessment to identify any other sources of lithium or lead acid batteries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067217 |
| MDR Report Key | 6249331 |
| Date Received | 2017-01-12 |
| Date of Report | 2017-01-12 |
| Date of Event | 2017-01-06 |
| Date Added to Maude | 2017-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 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 | 3 |
| Brand Name | MOBIUS POWER |
| Generic Name | LITHIUM BATTERY |
| Product Code | FCO |
| Date Received | 2017-01-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL MOBIUS POWER |
| Manufacturer Address | 1152 PARK AVE MURFREESBORO TN 37129 US 37129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-12 |