BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17405170 · Received July 27, 2023

    Report

    Report Number
    3001421318-2023-20263
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    September 7, 2021
    Report Date
    July 27, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 OF THE TECHNICAL SERVICE: NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN 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 WHILE THE VENTILATOR WAS USED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECT IP PROCESSOR BOARD WHICH WAS REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    THE CUSTOMER COMPLAIN ABOUT THE FUNCTIONALITY OF THE IP. THE IMAGE ON THE DISPLAY FREEZE AND THE WAVES ARE DELAYED RESPECT THE REAL TIME. OUR TECHNICIAN FOUND THE IP ESM VERY HOT AND HE CHANGE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222803 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown