BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16680015 · Received April 5, 2023

    Report

    Report Number
    3001421318-2023-01224
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 5, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE FOLLOWING CONCLUSION: FAILURE MODE DESCRIPTION: PHASE: START-UP. FAILURE EFFECT: WHEN THE OPTION MUDULE IS CONNECTED TO THE C6 HE UNIT DOES NOT TURN ON, SELFT TEST DO NOT START. WHEN THE OPTION MODULE NP 160185 IS DISCONNECTED THE UNIT WORKS OUT NORMALLY. ROOT CAUSE: FAULTY FFC CABLE TO INTERFACE BOARD PN 160658. CORRECTION: REPLACEMENT OF FFC CABLE TO INTERFACE BOARD PN 160658. NOTE: PLEASE NOTE THAT WE MODIFIED OUR REPORTING STRATEGY ON MARCH 15, 2023 AND THEREFORE WE NOW ASSESS THIS CASE AS REPORTABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: WHEN THE OPTION MODULE IS CONNECTED TO THE C6 THE UNIT DOES NOT TURN ON, SELF-TEST DOES NOT START. WHEN THE OPTION MODULE NP 160185 IS DISCONNECTED THE UNIT WORKS OUT NORMALLY. WHEN THE UNIT IS ON (STANDBY MODE) AND THEN WE CONNECT THE OPTION MODULE THE UNIT SHUT DOWN IMMEDIATELY. WE TESTED TWO OPTION MODULE NP 160185 IN THIS C6 AND THE UNIT DID NOT WORK WE INSTALLED THE OPTION MODULE IN OTHER UNITS AND THE MODULE WORK NORMALLY WE EXCHANGE THE CABLE PN 160658 AND THIS CABLE WAS WORKING WELL. SUMMARY: DEVICE DOES NOT START UP WITH CONNECTED OPTION BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212526 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160001 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown