BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND SCANNER FLEX FOCUS

    MDR report key: 24686373 · Received March 25, 2026

    Report

    Report Number
    3003705156-2026-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 25, 2026
    Manufacturer
    BK MEDICAL APS
    Product Code
    IYN
    PMA / PMN Number
    K123254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS COPENHAGEN - MILEPARKEN 34 DK 2730 DENMARK HERLEV. D2 COMMON DEVICE NAME: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC. D4 PRIMARY UDI NUMBER: UDI NOT REQUIRED. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE COMPLETED ITS INVESTIGATION. IT WAS NOT POSSIBLE TO DIRECTLY CONFIRM THE SPECIFIC BATTERY THAT INITIATED THE EVENT OR THE EXACT SEQUENCE OF FAILURE BECAUSE CRITICAL PHYSICAL EVIDENCE WAS EITHER UNAVAILABLE OR TOO DAMAGED FOR DEFINITIVE ANALYSIS. BASED ON THE AVAILABLE EVIDENCE, THE EVENT IS CONSISTENT WITH THE PRODUCT AND PROCESS-RELATED FAILURE MODE IDENTIFIED IN A PRIOR INVESTIGATION: A PROBABLE SINGLE-CELL LITHIUM-ION BATTERY FAILURE THAT RESULTED IN AN INTERNAL SHORT CIRCUIT AND THERMAL RUNAWAY. THE INVESTIGATION DID NOT IDENTIFY EVIDENCE OF A BROADER BATTERY DESIGN ISSUE. IT ALSO IDENTIFIED THAT THE USER GUIDE AND SERVICE MANUAL DID NOT CLEARLY COMMUNICATE BATTERY REPLACEMENT INTERVALS, END-OF-LIFE HANDLING, AND GENERAL BATTERY SAFETY PRECAUTIONS. CORRECTIVE ACTIONS HAVE BEEN INITIATED, INCLUDING CAPA AND FIELD SAFETY CORRECTIVE ACTION RES# 97830.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE SYSTEM WAS CONNECTED TO MAINS POWER AND OPERATING IN STAND BY MODE, VISIBLE FLAMES AND SMOKE WERE OBSERVED ORIGINATING FROM THE BATTERY COMPARTMENT. THE DEVICE WAS IMMEDIATELY ISOLATED AND REMOVED FROM THE OPERATING ROOM. DUE TO REPEATED BATTERY RE IGNITION, THE SYSTEM WAS SUBMERGED IN WATER OUTSIDE THE BUILDING. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751605 ULTRASOUND SCANNER FLEX FOCUS SEE H11 IYN BK MEDICAL APS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown