BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 17423010 · Received July 31, 2023

    Report

    Report Number
    8010042-2023-01454
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    July 31, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST WITH A MESSAGE 'SYSTEM VOLUME TOO LARGE' DURING PRE-USE CHECK. . THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER WHO OBSERVED THAT THE UNIT ALARMED FOR "SYSTEM VOLUME TOO LARGE" AND "LOW BATTERY CAPACITY". THE AIR GAS- AND O2 MODULES WAS REPLACED FURTHERMORE THE BATTERIES WERE REPLACED WITH NEW ONES FROM CUSTOMER STOCK WHICH RESOLVED THE REPORTED ISSUES. HOWEVER, DESPITE SEVERAL REMINDERS NO PARTS WAS RETURNED FOR INVESTIGATION. MOREOVER, DEVICE LOGS WERE NOT PROVIDED. THEREFORE, NO ROOT CAUSE CAN BE ESTABLISHED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST WITH A MESSAGE 'SYSTEM VOLUME TOO LARGE' DURING PRE-USE CHECK. THERE WAS NO PATIENT¿INVOLVEMENT. MANUFACTURER'S REF. #: 862594.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660645 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown