BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND SCANNER FLEX FOCUS

    MDR report key: 22108202 · Received May 29, 2025

    Report

    Report Number
    3003705156-2025-00002
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    April 29, 2025
    Report Date
    December 5, 2025
    Manufacturer
    BK MEDICAL APS
    Product Code
    IYN
    PMA / PMN Number
    K081154
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. THE INVESTIGATION INCLUDED INSPECTION OF THE BATTERY BY AN EXTERNAL THIRD-PARTY EXPERT. THE ROOT CAUSE WAS IDENTIFIED AS A SINGLE CELL FAILURE WITHIN A 6.5-YEAR-OLD LITHIUM-ION BATTERY, TRIGGERING AN INTERNAL SHORT CIRCUIT AND RESULTING IN THERMAL RUNAWAY. NO SYSTEMIC ISSUES WERE FOUND WITH THE BATTERY DESIGN; HOWEVER, IT WAS IDENTIFIED THAT THE USER GUIDE AND SERVICE MANUAL DO NOT ADEQUATELY STATE THE REQUIRED BATTERY REPLACEMENT INTERVALS, END-OF-LIFE HANDLING PROCEDURES, OR GENERAL BATTERY SAFETY PRECAUTIONS. A CAPA HAS BEEN INITIATED, WHICH INCLUDES A FIELD SAFETY CORRECTIVE ACTION (RES# 97830). D2 COMMON DEVICE NAME: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC. MEDICAL DEVICE PROBLEM CODE: A1009 - TEMPERATURE PROBLEM - SMOKING. CORRECTED DATA: D3 NAME.

    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, H6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2 D2 COMMON DEVICE NAME: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC. CORRECTED DATA D3 NAME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, SMOKE AND FLAMES WERE EMITTED FROM THE BATTERY PACK AREA OF THE SYSTEM. THE PROCEDURE WAS STOPPED, AND THE OPERATING ROOM WAS EVACUATED WHILE THE FIRE WAS EXTINGUISHED. NO INJURIES TO USERS OR PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597898 ULTRASOUND SCANNER FLEX FOCUS SEE H11 IYN BK MEDICAL APS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown