MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-21 for MOBIUS POWER MEDICAL CART BATTERY manufactured by Enovate Medical.
[6256282]
At 0144 in the morning, a lithium-ion battery used to power a hospital workstation on wheels caught fire while in its wall mounted charging station. A hospital staff member heard hissing and popping, followed by smoke then fire; 911 was called and the hospital's intensive care pts had to be evacuated. Five hospital staff members reported inhaling smoke, but no injuries otherwise resulted. Clean-up on the unit took a week to complete. This is the second time this year a battery from the same company has resulted in a fire within our hospital system. While the battery is not a medical device per se, the malfunction affected pt care. An ecri alert was released related to the matter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044781 |
| MDR Report Key | 4945812 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-06-04 |
| Date Added to Maude | 2015-07-28 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBIUS POWER MEDICAL CART BATTERY |
| Generic Name | LITHIUM-ION BATTERY FOR CART |
| Product Code | FCO |
| Date Received | 2015-07-21 |
| Returned To Mfg | 2015-06-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENOVATE MEDICAL |
| Manufacturer Address | MURFREESBORO TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-07-21 |