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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENOVATE MEDICAL/ STINGER MEDICAL MOBIUS POWER 3.5 BATTERY PACK MOBIUS POWER 3.5 BATTERY BOCK RECHARGEABLE

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ENOVATE MEDICAL/ STINGER MEDICAL MOBIUS POWER 3.5 BATTERY PACK MOBIUS POWER 3.5 BATTERY BOCK RECHARGEABLE Back to Search Results
Model Number MOBIUSPOWER
Device Problems Material Rupture (1546); Smoking (1585); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2017
Event Type  Injury  
Event Description
Staff heard noises and hissing from wall mounted battery charger and visually saw smoke. Staff unplugged charger from outlet. Smoke alarm was triggered. Code red was called, security and engineering arrived, and while speaking to staff, a loud "explosion" was heard from the wall charger assembly, which contained one battery pack. Engineering grabbed the fire extinguisher and doused the charging assembly and battery. The fire department arrived and the battery and charger was removed. No injuries were reported. Per fda h0260 01: any actions taken by the manufacturer/facility: manufacturer was notified and will replace all 3. 0 series battery packs immediately. Charging stations in remote, rarely occupied areas have been removed. All 3. 0 series battery packs have been removed from service. All other batteries have been visually inspected by is dept. Fire extinguishers have been added beside all remaining charging stations. Event has been reported internally to (b)(6) and also fda medwatch.
 
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Brand NameMOBIUS POWER 3.5 BATTERY PACK
Type of DeviceMOBIUS POWER 3.5 BATTERY BOCK RECHARGEABLE
Manufacturer (Section D)
ENOVATE MEDICAL/ STINGER MEDICAL
murfreesboro TN 37129
MDR Report Key6983180
MDR Text Key90768478
Report NumberMW5072979
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 Other Health Care Professional
Type of Report Initial
Report Date 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMOBIUSPOWER
Device Lot Number3ICP20/38/66-5
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/27/2017 Patient Sequence Number: 1
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