BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 21503360 · Received March 3, 2025

    Report

    Report Number
    8010042-2025-0000334
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON TECHNICIAN STATEMENT, THE VENTILATOR WAS CONTAMINATED BY WATER ON THE INHALATION SIDE. WATER WAS ELIMINATED; NO PART WAS REPLACED. WITHIN SERVO UNIT, THE ELECTRICAL PARTS ARE LOCATED INSIDE DEVICE, BENEATH THE COVER AND MECHANICALLY PROTECTED BY IT. THE UNIT HAS BEEN PRODUCED AFTER OF INTRODUCING NEW STANDARDS OF DEGREES OF PROTECTION AGAINST HARMFUL INGRESS OF WATER IEC 60601-1 ED.3. UNFORTUNATELY, THE DEVICE'S LOGS HAVE NOT BEEN PROVIDED, NO FURTHER ANALYSIS HAS BEEN POSSIBLE. AS NO MORE DETAILS REGARDING WHICH PART EXACTLY WERE AFFECTED AND CIRCUMSTANCES OF THE CONTAMINATION WERE PROVIDED, THE CAUSE OF THE ISSUE COULD NOT BE ESTABLISHED.

    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 WAS CONTAMINATED WITH WATER. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 1230605.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146886 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown