MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-23 for MOBIUS POWER * manufactured by Enovate Medical.
[21118697]
A nurse (rn) reported to engineering a burning electrical smell permeating throughout the wing. Engineering and security responded, searched and located a workstation on wheels (wow) with a flickering charger display and the strong smell of smoke next to an unoccupied patient bed. The unit was unplugged and transported to the ground floor utility area for storage until repaired. Several minutes later the utility area smoke alarm activated and the team responded to find the lithium-ion battery emitting smoke. The wow was transported to the back loading dock area and held to determine source of smoke and evaluation. The wow's batteries then began to spark and emit large flames several times. The team then sprayed the wow with a dry soda based extinguisher and placed the device into an empty metallic bin where it continued to flame up and melt the battery and workstation. City fire was dispatched and biomedical was contacted to determine next steps approximately an hour and a half later. City fire contained equipment until there was no further burning of the device and handed it off to hospital biomedical and it collaborated to contact manufacturer and submit adverse event report. No patient harm or care area evacuation occurred due to this event. The manufacturer is determining further plan of action on retrieving devices for analysis and report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4881673 |
| MDR Report Key | 4881673 |
| Date Received | 2015-03-23 |
| Date of Report | 2015-03-23 |
| Date of Event | 2015-03-23 |
| Report Date | 2015-03-23 |
| Date Reported to FDA | 2015-03-23 |
| Date Reported to Mfgr | 2015-07-01 |
| Date Added to Maude | 2015-07-01 |
| 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 |
| 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 | WORKSTATION, MOBILE, BATTERY OPERATED |
| Product Code | FCO |
| Date Received | 2015-03-23 |
| Model Number | MOBIUS POWER |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL |
| Manufacturer Address | 1152 PARK AVENUE MURFREEBORO TN 37129 US 37129 |
| Brand Name | MOBIUS POWER |
| Generic Name | BATTERY, LITHIUM ION |
| Product Code | FCO |
| Date Received | 2015-03-23 |
| Model Number | MOBIUS POWER 26 AH |
| Catalog Number | HC20-MB-1B06 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL |
| Manufacturer Address | 1152 PARK AVENUE MURFREEBORO TN 37129 US 37129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-23 |