MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-31 for ENOVATE CART EMC T.CD CART WITH L.I PHOA BATTERY, ELECTRONIC LIFT ACTUATOR AND C HCO 14458 manufactured by .
[4219143]
On this date an equipment cart that has a battery pack was found smoking (the battery pack) by a nurse and the staff peppered it with a fire extinguisher to stop the smoking. This was treated as a potential fire situation on the unit. A enovate care serial # (b)(4) with a li-phoa battery, electronic lift actuator and configured with medication drawers was involved in the event. No damages or injuries but the area required major clean up due to extensive fire extinguisher residue and pts were relocated to another unit. The cart was used to assist staff in dispensing medications and pt charting. The cart was pulled the services and wiring/cables in battery compartment were found to be melted. All other carts in the facility were systematic checked for the same problem and only one other cart was found to have a similar problem (hco # 14829) and both pulled from manufacturer. (http://www. Enovatemedical. Com/support. Html). The devices were returned to the vendor engineers to investigate the cause and determine if any solutions are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033713 |
| MDR Report Key | 3556404 |
| Date Received | 2013-12-31 |
| Date of Report | 2013-12-31 |
| Date of Event | 2013-11-07 |
| Date Added to Maude | 2014-01-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENOVATE CART EMC T.CD CART WITH L.I PHOA BATTERY, ELECTRONIC LIFT ACTUATOR AND C |
| Generic Name | WHEELED CART |
| Product Code | BZN |
| Date Received | 2013-12-31 |
| Returned To Mfg | 2013-11-14 |
| Model Number | HCO 14458 |
| Lot Number | PO # 9011062 |
| Device Expiration Date | 2011-02-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Brand Name | ENOVATE CART EMC T.CD CART WITH L.I PHOA BATTERY, ELECTRONIC LIFT ACTUATOR AND C |
| Generic Name | WHEELED CART |
| Product Code | BZN |
| Date Received | 2013-12-31 |
| Returned To Mfg | 2013-11-14 |
| Model Number | HCO 14829 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-31 |