BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT, SERVO-AIR

    MDR report key: 20367447 · Received October 4, 2024

    Report

    Report Number
    8010042-2024-0001627
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 4, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710003114
    PMA / PMN Number
    K192604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAD FAILED THE INTERNAL LEAKAGE TEST DURING THE PRE-USE CHECK (PUC). THE PUC WAS PERFORMED DURING THE PREVENTIVE MAINTENANCE (PM) OF THE DEVICE BY OUR FIELD SERVICE ENGINEER. DURING TROUBLESHOOTING, THE EXPIRATORY CASSETTE WAS REPLACED, BUT THIS DID NOT RESOLVE THE PUC FAILURE. THE INSPIRATORY PIPE AND THE EXPIRATORY CHANNEL PCB WERE REPLACED BUT THIS DID NOT RESOLVED THE THE INTERNAL LEAKAGE TEST FAILURE DURING THE PUC. THEN BOTH PRESSURE TRANSDUCER PRINTED CIRCUIT BOARDS (PCBS) WERE REPLACED AND THE ISSUE WAS SOLVED AND THE DEVICE PASSED ALL FUNCTIONAL, SAFETY, AND CALIBRATION TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. NO LOGS WERE PROVIDED. THE INSPIRATORY PIPE, THE EXPIRATORY CHANNEL PCB, AND THE PRESSURE TRANSDUCER PCBS WERE ALL RETURNED FOR FURTHER INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PARTS REVEALED NO ABNORMALITIES. ALL THE PARTS WERE FIRST SEPARATELY PLACED INTO A REFERENCE VENTILATOR FOR SIMULATED USE TESTING, WHERE THEY PASSED MULTIPLE PUCS. AFTER THIS, ALL PARTS WERE PLACED IN THE SAME VENTILATOR, AND THE DEVICE PASSED SEVERAL PUCS. FOLLOWING THIS, VENTILATION WAS SUCCESSFULLY PERFORMED FOR SEVERAL DAYS WITHOUT GENERATING ANY ALARMS OR ERRORS. AFTER VENTILATION, SEVERAL PUCS WERE CONDUCTED, ALL OF WHICH PASSED. THE REPORTED ISSUE COULD NOT BE REPRODUCED AT THE MANUFACTURER SITE; THEREFORE, A DEFINITE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS MOMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703998 BASE UNIT, SERVO-AIR VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6882000 07325710003114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown