MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for ENOVATE MEDICAL 8116270 manufactured by Enovate Medical.
[91850926]
At 01:36 on (b)(6) 2017 a nurse discovered that an enovate mobius lithium battery was smoking, while being kept in a battery charger. (these batteries are used to power our fleet of enovate sydekick computer carts. ) the nurse took the battery outside via elevator. Once outside, the battery burst into flame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073262 |
| MDR Report Key | 7025546 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-26 |
| Date Added to Maude | 2017-11-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | ENOVATE MEDICAL |
| Generic Name | BOX, BATTERY, RECHARGEABLE |
| Product Code | FCO |
| Date Received | 2017-11-13 |
| Model Number | 8116270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL |
| Manufacturer Address | MURFREESBORO TN 37129 US 37129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |