BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18372215 · Received December 21, 2023

    Report

    Report Number
    3001421318-2023-27642
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    July 22, 2020
    Report Date
    December 20, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 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 PREPARED FOR TREATMENT. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE WHICH LED TO THE DEFORMATION OF THE METAL PLATE OF THE EXPIRATORY VALVE MEMBRANE. THIS DEFORMATION IS CAUSED BY THE ASSEMBLY OF THE PROTECTION CAP ONTO THE EXPIRATORY VALVE SET. THE ISSUE WAS ADDRESSED BY A MATERIAL CHANGE AND A NEW DEVICE FOR ASSEMBLY. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    BATCH OF MULTIPLE C6 EXPIRATORY VALVES (160176) CONSISTENTLY FAILING TIGHTNESS TESTS DUE TO A SMALL DENT IN THE METAL MEMBRANE ON THE EXTERIOR OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289027 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown