BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 21034072 · Received December 30, 2024

    Report

    Report Number
    8010042-2024-0002147
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 30, 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
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE WAS CONFIRMED BY PROVIDED PROBLEM DESCRIPTION AND PHOTO SHOWING THE HUMIDIFIER HOLDER ARM BEING ANGLED FROM THE PLATE INTENDED TO BE INSERTED INTO THE RAIL CLAMP MOUNTED ON THE VENTILATOR CARRIER. THE CONSEQUENCE OF THIS KIND OF MECHANICAL DAMAGE IS THAT THE HUMIDIFIER GETS DETACHED AND, IN A WORST-CASE SCENARIO, FALLS OFF THE VENTILATOR CARRIER. OUR CONCLUSION INTO THIS MATTER IS THAT THE HUMIDIFIER HOLDER MOST LIKELY HAS BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCREW OF HUMIDIFIER HOLDER BROKE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 1181260.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428502 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800 07325710000823

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown