BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17624033 · Received August 25, 2023

    Report

    Report Number
    3001421318-2023-20823
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 13, 2021
    Report Date
    August 24, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION UNTIGHT OR DEFECTIVE PRESSURE SENSOR BOARD/ASSEMBLY OR UNTIGHT OR DEFECTIVE AUTOZERO VALVE" LED TO AN INOPERABLE VENTILATOR. THE ROOT CAUSE OF THE VENTILATOR WAS A MALFUNCTION OF THE PRESSURE SENSOR ASSEMBLY. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE.

    Description of Event or Problem · 0

    ALARMING WHEN STARRTING UP AND SELF TEST FAILED. TECHNICAL EVENTS: 285002, 285002, 233001, 23304, 233003, 233006, 246005, 232035.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918418 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown