BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17592374 · Received August 21, 2023

    Report

    Report Number
    3001421318-2023-28265
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    May 21, 2020
    Report Date
    August 21, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE EFFECT IN ALL 33 CASES WAS A BLANK DISPLAY. THE ROOT CAUSE IN ALL CASES WAS IDENTIFIED AS A DEFECTIVE FRONT PANEL BOARD. AFTER REPLACING THIS PART AS CORRECTION, THE UNITS WERE WORKING AS REQUIRED. THE IDENTIFIED ROOT-CAUSE DOCUMENTED IN KY2HELP CAN BE CONFIRMED. FOR THE REFERENCE CASE CER 81291, FOLLOWING THE CORRECTION, NO FURTHER COMPLAINTS WERE RECEIVED FOR THE DEVICE SINCE 2020. THERE WAS NO INDICATION THAT THE COMPLAINTS LED TO DEATH, INJURY, OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT AND OPERATOR. THERE WAS NO VENTILATION. SINCE THE COMPLAINTS 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 THEIR SPECIFICATIONS AT THE TIME OF THE EVENT, WHILE THE VENTILATOR WAS IN OPERATION.

    Description of Event or Problem · 0

    VENTILATOR TURN ON BUT WHEN STARTUP TEST COMPLETE THE DISPLAY BECOMES BLACK. WE CHECK AND FOUND WHEN WE DISCONNECT CABLE FFC CABLE TO FRONT PANEL BOARD C3( 160568), IT SHOWS DISPLAY BUT WHEN WE CONNECT AGAIN ITS DISPLAY BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339962 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown