MAUDE Adverse Event Report: ENOVATE MEDICAL ENOVATE MEDICAL; BOX, BATTERY, RECHARGEABLE

Model Number 8116270

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Information (3190)

Event Date 10/26/2017

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: ENOVATE MEDICAL
• Type of Device: BOX, BATTERY, RECHARGEABLE
• Manufacturer (Section D): ENOVATE MEDICAL; murfreesboro TN 37129
• MDR Report Key: 7025546
• MDR Text Key: 91850926
• Report Number: MW5073262
• Device Sequence Number: 1
• Product Code: FCO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Device Operator: Health Professional
• Device Model Number: 8116270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1