BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 21343061 · Received February 10, 2025

    Report

    Report Number
    8010042-2025-0000223
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 10, 2025
    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 FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. ACCORDING TO INFORMATION RECEIVED IN THE SERVICE REPORT, THE DEVICE FAILED INTERNAL LEAKAGE TEST, PRESSURE TRANSDUCER TEST AND PATIENT CIRCUIT TEST DURING PRE-USE CHECK. REPLACEMENT OF THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD (PCB) SOLVED THE ISSUE. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. THE DEFECTIVE PART WAS NOT RETURNED FOR INVESTIGATION, DESPITE REQUEST. PRESSURE TRANSDUCER PCB 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 CAUSE OF THE CLAIMED ISSUE IN THIS CUSTOMER PRODUCT COMPLAINT HAS BEEN DETERMINED. THE ISSUE WAS RELATED TO PRESSURE TRANSDUCER PCB.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT THE VENTILATOR FAILED MULTIPLE TESTS DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: 1220589.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835755 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown