BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17735331 · Received September 13, 2023

    Report

    Report Number
    3001421318-2023-28780
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    April 6, 2020
    Report Date
    September 12, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE AMBIENT VALVE CAUSING THE APPEARANCE OF THE MESSAGE "RELEASE VALVE DEFECTIVE" (NO VENTILATION, NO PATIENT INVOLVEMENT). 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. 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 WHILE IT WAS PREPARED FOR TREATMENT.

    Description of Event or Problem · 0

    RELASE VALVE DEFECTIVE. AMBIENT VALVE AND TIGHTNESS TEST NOK OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87957 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown