BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND SCANNER SYSTEM 2300

    MDR report key: 20050894 · Received August 23, 2024

    Report

    Report Number
    3003705156-2024-00001
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    BK MEDICAL APS (PART OF GE HEALTHCARE)
    Product Code
    IYN
    UDI-DI
    05704916000264
    PMA / PMN Number
    K222441
    Removal / Correction Number
    9680269-09/12/24-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT ROOT CAUSE WAS CONCLUDED TO BE: THE INTERNAL POWER CONNECTION AT THE POWER INLET OF THE DEVICE CAME LOOSE. THIS LED TO A GAP BETWEEN THE POWER CONNECTOR AND Y-SPLITTER (THE Y-SPLITTER IS A POWER SPLITTER COMPONENT THAT SPLITS MAINS POWER FROM 1 INPUT TO 2 OUTPUTS), WHICH FURTHER LED TO THE THERMAL EVENT.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINT, A CUSTOMER REPORTED A THERMAL EVENT ON THEIR BK3000 SYSTEM (S/N: (B)(6) ). WHILE RECHARGING IN ANOTHER ROOM ABOUT AN HOUR AFTER THE PROCEDURE, IT WAS NOTICED THAT SMOKE WAS COMING FROM THE ROOM AND A FIRE IN THE POWER SUPPLY AT THE BASE OF THE MACHINE WAS OBSERVED. UPON OBSERVATION, THE FIRE WAS EXTINGUISHED. NO HARM TO PATIENTS OR USERS HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364411 ULTRASOUND SCANNER SYSTEM 2300 BK3000 ULTRASOUND SYSTEM W/BATTERY IYN BK MEDICAL APS (PART OF GE HEALTHCARE) 2300-11 05704916000264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown