ENOVATE MEDICAL 8116270

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5073262
MDR Report Key7025546
Date Received2017-11-13
Date of Report2017-11-09
Date of Event2017-10-26
Date Added to Maude2017-11-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENOVATE MEDICAL
Generic NameBOX, BATTERY, RECHARGEABLE
Product CodeFCO
Date Received2017-11-13
Model Number8116270
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerENOVATE MEDICAL
Manufacturer AddressMURFREESBORO TN 37129 US 37129


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-13

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