BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 20543988 · Received October 28, 2024

    Report

    Report Number
    8010042-2024-0001766
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 23, 2024
    Report Date
    October 28, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710000823
    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 DISTRIBUTOR'S FIELD SERVICE ENGINEER. THE CLAIMED ISSUE WAS REPRODUCED DURING TROUBLESHOOTING. ACCORDING TO RECEIVED INFORMATION IN SERVICE REPORT, THE REPLACEMENT OF THE CONTROL PRINTED CIRCUIT BOARD SOLVED THE ISSUE. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. CONTROL PRINTED CIRCUIT BOARD CONTAINS ELECTRONICS (INCLUDING MICROPROCESSOR) RESPONSIBLE FOR I.A. FOR INSPIRATORY PRESSURE REGULATION WHICH CAN BE USED DURING INSPIRATION TIME IN ANY MODE. THE DEVICE'S LOGS AND CLAIMED PART WERE NOT PROVIDED FOR FURTHER ANALYSIS. OUR CONCLUSION IS THAT THE REPLACED PART WAS THE CAUSE OF THE FAILURE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED TECHNICAL ERROR CODE INDICATING AN ERROR IN THE INTERNAL MEMORY. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 1152158

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891223 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown