MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for ENOVATE MEDICAL MOBIUS POWER 3118313 3118313 3316900 manufactured by Enovate Medical.
[62791690]
On (b)(6) 2016, at approx 0850am, a wow battery, in the changing bay located in an in-patient storage area failed, causing a battery de-passion issue. This failure produced a noxious electrical overheating odor, and soot from the failed battery cell on the battery, and on the charger unit. Teams from engineering reported to the location and determined the danger was contained, and the code red could be cancelled, without the (b)(6) fire department responding to the event. The it team also reported to the location, removed the failed battery, the charger, along with 3 add'l batteries that were in the charger. These 3 batteries did not display signs of drainage. The resulting noxious order resulted in a re-location of pts on that wing, and a staff member suffered asthma related symptoms resulting in the need to go to the ed. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066736 |
| MDR Report Key | 6181815 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-12-13 |
| Date Added to Maude | 2016-12-16 |
| 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 | ENOVATE MEDICAL MOBIUS POWER |
| Generic Name | MOBIUS POWER IND. BATTERY 26AH |
| Product Code | FCO |
| Date Received | 2016-12-15 |
| Model Number | 3118313 |
| Catalog Number | 3118313 3316900 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL |
| Manufacturer Address | MURFREESBORO TN 37129 US 37129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4 | 2016-12-15 |