BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17681176 · Received September 5, 2023

    Report

    Report Number
    3001421318-2023-20563
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 23, 2021
    Report Date
    September 1, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE IN THIS CER IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION 'VENTILATION STOPPED ON PATIENT' WHICH CAUSES THE DEVICE TO SWITCH TO AMBIENT STATE DURING VENTILATION WILL CAUSE THE VENTILATOR TO BECOME INOPERABLE OR STOP WORKING AS INTENDED. THE ROOT CAUSE OF THE VENTILATOR DEVICE IS ASSUMED TO BE A DEFECTIVE VU ESM BOARD. A DETAILED INVESTIGATION WAS NOT POSSIBLE BECAUSE THE CUSTOMER DID NOT RETURN THE DEFECTIVE ESM BOARD. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE IT WAS USED FOR TREATMENT OR DIAGNOSIS. THERE ARE CONFLICTING PIECES OF INFORMATION IN THE COMPLAINT DATABASE. ON THE ONE HAND, IT IS STATED IN THE "ADDITIONAL EVENT INFORMATION" SECTION THAT NO PATIENT, USER OR THIRD PARTY WAS HARMED. ON THE OTHER HAND, IN THE COMPLAINT / FAILURE INFORMATION SECTION IT IS STATED THAT THE DEVICE FAILURE "CAUSED ADDITIONAL TREATMENT TO BE NECESSARY". HAMILTON MEDICAL AG AND HAMILTON MEDICAL INC. TRIED SEVERAL TIMES OVER A PERIOD OF ALMOST ONE YEAR TO CONTACT THE CUSTOMER (CENTRAL VERMONT MEDICAL CENTER) AND FIND OUT MORE ABOUT WHAT HAPPENED. THE CUSTOMER DID NOT REPLY. AS THE COMPLAINT THIS CER WAS SUBMITTED TO HAMILTON MEDICAL AG OVER 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED ANYMORE TO OBTAIN ADDITIONAL INFORMATION. THE ALLEGATION IN THIS CER WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE.

    Description of Event or Problem · 0

    DEAR SVEN THIS UNIT FAILED DURING VENTILATION BEFORE THE PHENOMENA THAT YOU CAN SEE IN THE VIDEO THE UNIT ALERTED WITH TF 249012 . THE ONLY WAY TO SHUT DOWN THE UNIT WAS TO TAKE OUT THE BATTERY . WE CAN SEE IN THE LOGS THAT THE TEMP WAS OVER 64 DEGREES IS IT NORMAL ? PLEASE ADVISE BR LIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170144 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown