BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 20365922 · Received October 4, 2024

    Report

    Report Number
    8010042-2024-0001620
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 4, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIELD SERVICE ENGINEER INVESTIGATED THE DEVICE ON-SITE, WHERE THE ISSUE WAS CONFIRMED. DURING TROUBLESHOOTING, THE EXPIRATORY CASSETTE WAS REPLACED, BUT THIS DID NOT RESOLVE THE PUC FAILURE. UPON FURTHER INSPECTION, THE INSPIRATORY PIPE MEMBRANE WAS FOUND TO BE DEFECTIVE, AND THE INSPIRATORY PIPE WAS REPLACED. AFTER REPLACEMENT, THE PUC PASSED INTERMITTENTLY; AFTER A FEW PUCS, THE INTERNAL LEAKAGE TEST FAILED AGAIN. THIS INTERMITTENT PUC FAILURE WAS SOLVED BY REPLACING BOTH PRESSURE TRANSDUCER PRINTED CIRCUIT BOARDS (PCBS) AND THE EXPIRATORY CHANNEL PCB. AFTER REPLACING ALL THE PCBS, THE DEVICE PASSED ALL FUNCTIONAL, SAFETY, AND CALIBRATION TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. ANALYSIS OF THE PROVIDED DEVICE LOGS CONFIRMED THE REPORTED ISSUE WITH THE FAILED INTERNAL LEAKAGE TEST DURING THE PUC. 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.

    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 DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442811 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown