BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 19115253 · Received April 16, 2024

    Report

    Report Number
    8010042-2024-00627
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    April 12, 2024
    Report Date
    April 16, 2024
    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

    ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. ACCORDING TO RECEIVED SERVICE REPORT, REPLACEMENT OF THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD SOLVED THE ISSUE. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD MEASURES THE PRESSURE, CONVEYED VIA THE PRESSURE TUBE CONNECTED TO THIS BLOCK BY ITS DIFFERENTIAL PRESSURE TRANSDUCER. WITH DIFFERENTIAL REFERENCE TO THE AMBIENT PRESSURE, THE OUTPUT SIGNAL IS PROPORTIONAL TO THE MEASURED PRESSURE THUS GIVING A LINEAR MEASUREMENT IN THE RANGE -40 CMH2O TO +160 CMH2O. THE ROOT CAUSE OF THE REPORTED ISSUE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST AND PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 1022777.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672439 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown