BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 18001355 · Received October 25, 2023

    Report

    Report Number
    8010042-2023-02069
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Report Date
    October 25, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 TECHNICIAN STATEMENT, REPLACEMENT OF BOTH PRESSURE TRANSDUCER PRINTED CIRCUIT BOARDS (PCB) 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. EVALUATION OF RECEIVED DEVICE LOGS, CONFIRMED THE CLAIMED PRESSURE TRANSDUCER TEST FAILURE. OUR CONCLUSION IS THAT THE REPLACED PARTS WERE THE CAUSE OF THE FAILURE. HOWEVER, THE ROOT CAUSE TO WHY THE PART FAILED HAS NOT BEEN ESTABLISHED AS THE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    **DEVICE RELATED DATA QUALITY UPDATES ONLY** A CORRECTION OF FIELDS # D1 BRAND NAME AND # D4 VERSION OR MODEL # WERE REQUIRED. D1 ¿ BRAND NAME - PREVIOUS BRAND NAME: SERVO-S, CORRECTED BRAND NAME: SERVO-S BASE UNIT D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: SERVO-S, CORRECTED VERSION OR MODEL #: 6640440. THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 914826.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733365 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown