BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18380303 · Received December 21, 2023

    Report

    Report Number
    3001421318-2023-29152
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    March 2, 2020
    Report Date
    December 20, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    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 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: THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION TIGHTNESS TEST FAILURE' DUE TO LEAKY EXPIRATION VALVE ASSEMBLY CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED. A NEW VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE OF THE VENTILATOR TO ALARM WITH "TIGHTNESS TEST FAILURE" WAS A MALFUNCTION OF THE EXPIRATION VALVE ASSEMBLY CAUSING A LEAK. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS PREPARED TO BE USED FOR TREATMENT OR DIAGNOSIS (PREOP CHECK). THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. 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.

    Description of Event or Problem · 0

    EXPIRATION VALF TEST NOT OK. TIGHTNESS TEST NOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035395 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown