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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENOVATE MEDICAL MOBIUS POWER MOBIUS POWER LITHIUM BATTERY

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ENOVATE MEDICAL MOBIUS POWER MOBIUS POWER LITHIUM BATTERY Back to Search Results
Device Problems Fire (1245); Smoking (1585); Noise, Audible (3273)
Patient Problem Injury (2348)
Event Date 01/06/2017
Event Type  Injury  
Event Description
At approx 10:54 am on (b)(6) 2017, a popping sound was heard coming from a mobile workstation battery charger. The unit then started to produce a large amount of smoke and flame. Three batteries were included with one being completely destroyed. The fire was suppressed. The fire caused a great amount of smoke resulting in evacuation of the pt care unit to a different floor. Two visitors and four staff members were treated for smoke inhalation. No pts were involved or harmed. The battery was being charged at the time. The mfr is replacing all batteries and chargers with a newer model. The organization is performing a risk assessment to identify any other sources of lithium or lead acid batteries.
 
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Brand NameMOBIUS POWER
Type of DeviceLITHIUM BATTERY
Manufacturer (Section D)
ENOVATE MEDICAL MOBIUS POWER
1152 park ave
murfreesboro TN 37129
MDR Report Key6249331
MDR Text Key64766116
Report NumberMW5067217
Device Sequence Number0
Product Code FCO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Type of Device Usage

Patient Treatment Data
Date Received: 01/12/2017 Patient Sequence Number: 1
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