BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VSCAN EXTEND DUAL

    MDR report key: 8737525 · Received June 26, 2019

    Report

    Report Number
    9610482-2019-00002
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    May 28, 2019
    Report Date
    August 30, 2019
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K180995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GE'S INVESTIGATION HAS COMPLETED. THE ACTUAL DEVICE WAS EVALUATED, AND IT WAS DETERMINED THAT THERE IS NO EVIDENCE TO INDICATE THAT THIS FAILURE WAS DUE TO A PUNCTURE OF THE BATTERY. IT WAS CAUSED BY THE PRESSURE OF THE BACK OF THE PHONE BEING REPLACED. THIS INCREASED THE PRESSURE WITHIN THE BATTERY RESULTING IN GASES BEING VENTED AND SUBSEQUENT IGNITION LEADING TO A FIRE. COMPLAINT AND SERVICE DATA WAS REVIEWED AND NO OTHER OCCURRENCE OF THE VSCAN EXTEND BURSTING INTO FLAMES COULD BE FOUND. HOWEVER, OTHER INSTANCES OF BULGING BATTERIES WERE NOTED, AND THE INVESTIGATION TURNED TO TRYING TO REPRODUCE THE ISSUE USING BULGING BATTERIES. THIS TESTING CONCLUDED BATTERY BULGING BY ITSELF DID NOT CAUSE THE VSCAN EXTEND TO BURST INTO FLAMES. IT WAS FURTHER CONCLUDED THAT BATTERY BULGING OCCURS WHEN AN AGING BATTERY MAINTAINS A 100% STATE OF CHARGE (I.E. DOESN'T GET DISCHARGED PROPERLY) DUE TO A LACK OF CHARGE/DISCHARGE MANAGEMENT VIA SOFTWARE, WHICH IS CURRENTLY THE DESIGN OF THE VSCAN EXTEND. THEREFORE, GE'S ACTIONS TO ADDRESS THE BULGING BATTERIES IS TO CHANGE THE SOFTWARE DESIGN GOING FORWARD TO ALLOW FOR PROPER CHARGING/DISCHARGING CYCLES. ADDITIONALLY, SERVICE PROCEDURES FOR HANDLING A BULGING BATTERY OF A VSCAN EXTEND WERE REVIEWED AND IT HAS BEEN CONCLUDED THAT CURRENT PROCEDURES FOR REPLACEMENT AND DISPOSAL ARE ADEQUATE.

    Additional Manufacturer Narrative · 1

    (B)(4). LEGAL MANUFACTURER: HCS (B)(4) - (B)(4).

    Description of Event or Problem · 1

    WHILE A VSCAN EXTEND WAS UNDERGOING REPAIR THE REPAIR TECHNICIAN NOTED THE BATTERY COVER WAS BULGING AND NOT COMPLETELY SECURED. THE TECHNICIAN PRESSED THE COVER IN AN ATTEMPT TO CLOSE IT WHEN THE BATTERY SPARKED, AND SHORTLY AFTERWARDS STARTED SMOKING AND THEN BURST INFO FLAMES. NO INJURY OR PROPERTY DAMAGE OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531615 VSCAN EXTEND DUAL DIAGNOSTIC ULTRASOUND SYSTEM IYN GE VINGMED ULTRASOUND AS H41212RN

    Patients

    Seq Age Sex Outcome Treatment
    1