BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18323995 · Received December 14, 2023

    Report

    Report Number
    3001421318-2023-28592
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    April 24, 2020
    Report Date
    December 13, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN THE FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE FDC CABLE PN160357. AFTER REPLACING THE PART AS CORRECTION, THE UNIT WAS WORKING AS REQUIRED. THERE WAS NO PATIENT OR USER HARM. THE IDENTIFIED ROOT CAUSE WAS CONFIRMED.

    Description of Event or Problem · 0

    I HAVE AN QUALITY ISSUE ABOUT THE CABLE "FDC TO DISPLAY (PN:160386)" WHICH IS SO FRANGIBLE. THE CONNECTOR IS EASILY SEPARATED FROM THE CABLE. PLEASE FIND THE FOLLOWING PICTURE. IN ORDER TO CHECK THE MACHINE, I NEED TO PLUCK THE CABLE MANY TIME. BUT THE DESIGN OF THE SCREEN IS DIFFICULT TO HOLD, SO WE MUST DO IT VERY CAREFULLY. HOWEVER THERE ARE TWO OF THEM BROKEN. AND EVEN SOME ARE BROKEN INSIDE WITHOUT ANYONE OPEN IT. IM NOT SURE IF ITS ALSO HAPPENED IN OTHER COUNTRY, BUT IT OCCURRED MANY TIMES EVEN WITH NEW UNITS. PLEASE HELP US CHECK THE ISSUE AND OFFER US THE SOLUTION. THANKS FOR YOUR KIND HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824660 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown