BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17411662 · Received July 28, 2023

    Report

    Report Number
    3001421318-2023-02777
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 28, 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
    505

    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 232056.(PLAUSIBILITY BETWEEN PAMBIENT AND PFILTER FAILED) FIND FILTER PRESSURE SENSOR BOARD DEFECTIVE , AFTER REPLACE NEW PART THIS C1 CAN USE TO BE NORMALLY. NO PATIENT INVOLVEMENT. HAMILTON MEDICAL AG ADDITION: THE DEVICE COULD NOT BE STARTED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929709 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown