BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIQ E9 BREAKTHROUGH 2013

    MDR report key: 16599966 · Received March 23, 2023

    Report

    Report Number
    3005860720-2023-00002
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 3, 2023
    Report Date
    May 17, 2023
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG
    Product Code
    IYN
    PMA / PMN Number
    K123564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S (GEHC) INVESTIGATION HAS CONCLUDED WITH ADDITIONAL INFORMATION COLLECTED FROM THE CUSTOMER AND VISUAL INSPECTION OF THE DAMAGED LOGIQ E9. IT WAS DETERMINED THAT THE LOGIQ E9 WAS LEFT POWERED ON AND UNATTENDED IN A CLOSED ROOM WHEN IT CAUGHT FIRE. THE FACILITY FIRE ALARM AND SPRINKLER SYSTEM WERE NOT TRIGGERED, AND THE FACILITY CIRCUIT BREAKER DID NOT TRIP. POTENTIAL CAUSES WERE EVALUATED TO DETERMINE THE LIKELIHOOD OF THIS INCIDENT OCCURRING IN THE FUTURE INCLUDING HISTORICAL SYSTEM DATA AS WELL AS THE LOGIQ E9 COMPLAINT FILE. THERE HAVE BEEN NO THERMAL EVENTS RESULTING IN SYSTEMS CATCHING FIRE, AND THERE ARE NO SYSTEMIC DEFICIENCIES OBSERVED WITH THE LOGIQ E9. THE SPECIFIC ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED AT THIS TIME BASED UPON THE INFORMATION AVAILABLE. BASED UPON THE VISUAL INSPECTION AND INFORMATION COLLECTED ABOUT THE INCIDENT GEHC'S INVESTIGATION CONCLUDED THAT THE FIRE MAY HAVE STARTED FROM LINT BUILDUP WITHIN THE POWER SUPPLY WHICH IGNITED, AND THEN THE POWER SUPPLY COOLING FAN BLEW THOSE FLAMES ONTO THE SYSTEM ENCLOSURE AND POWER CAUSING THOSE TO ALSO CATCH FIRE. THE RESIDUAL RISK HAS BEEN DETERMINED TO BE REDUCED AS FAR AS POSSIBLE (AFAP) AND NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    NO PATIENT WAS INVOLVED. UDI: PRE-COMPLIANCE, NO UDI. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED TO GEHC THAT THE BACK OF A LOGIQ E9 HAD CAUGHT FIRE AND THE CAUSE OF THE FIRE IS UNKNOWN. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493491 LOGIQ E9 BREAKTHROUGH 2013 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM IYN GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAG UGLG9M 110278US9

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown