BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17736379 · Received September 13, 2023

    Report

    Report Number
    3001421318-2023-11888
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    July 31, 2022
    Report Date
    September 12, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 DEFECTIVE PRESSURE SENSOR ASSEMBLY. IN CONSEQUENCE THE CORRECTION TO REPLACE THE DEFECTIVE PRESSURE SENSOR ASSEMBLY RECTIFIED THE ISSUE. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    THE UNIT SHOWED 231022 ((B)(6) 2022 07:53:04) DURING WORKING. WE TESTED IT WITH TEST LUNG AND HAPPENED THE SAME PROBLEM. WE CONFIRMED THAT THE PRESSURE SENSOR BOARD WAS BROKEN. AFTER THE NEW REPLACING PRESSURE SENSOR BOARD, IT IS FINE NOW. TSW (PRE) :(B)(6) 202210:52:33 TSW (POST): /(B)(6) 2022 11:31:16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70479 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown