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U.S. Department of Health and Human Services

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

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ENOVATE MEDICAL ENOVATE MEDICAL BOX, BATTERY, RECHARGEABLE Back to Search Results
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.
 
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Brand NameENOVATE MEDICAL
Type of DeviceBOX, BATTERY, RECHARGEABLE
Manufacturer (Section D)
ENOVATE MEDICAL
murfreesboro TN 37129
MDR Report Key7025546
MDR Text Key91850926
Report NumberMW5073262
Device Sequence Number1
Product Code FCO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2017
Device Operator
Device Model Number8116270
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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