BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17316957 · Received July 13, 2023

    Report

    Report Number
    3001421318-2023-02622
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 6, 2023
    Report Date
    July 13, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ALARM 233001 (PVENT_MONITOR AUTOZERO FAILED) , 232002 (PVENT_MONITOR DEFECT). INTO SERVICE SOFTWARE FIND "BINARY VALVE TEST FAILED" AND "AUTO ZERO VENT TEST FAILED". AFTER EXCHANGE NEW "PRESSURE SENSOR" THIS VENTILATOR CAN USE TO BE NORMALLY. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260813 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown