BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18542923 · Received January 19, 2024

    Report

    Report Number
    3001421318-2023-25832
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    November 22, 2020
    Report Date
    January 19, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 MORE THAN TWO YEARS AGO, NO ATTEMPTS WILL BE MADE 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 LIKE 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 WHILE THE VENTILATOR WAS TURNED ON. THE MOST PROBABLE ROOT CAUSE IS AN RAM INITIALIZATION PROBLEM DURING STARTUP WHICH WAS RESOLVED WITH SW2.2.4. A RESTART OF THE VENTILATOR RESOLVED THE ISSUE. A SW UPDATE TO VERSION 2.2.4 WAS RECOMMENDED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    DEAR SVEN THIS UNIT ACCORDING TO THE USTOMER ALARMED WITH : 431015 ACCORDING TO THE KEY 2 HELP THERE IS A NEED TO CHECK : CORRECTION: -RESTART THE VENTILATOR -CHECK FOR BLOWER IN SERVICE SW (BLOWER PRESSURE, BLOWER FLOW) -IF THE PROBLEM REAPPEARS, REPLACE DRIVER BOARD (NOISE REDUCTION WITH DRIVER BOARD 161498/04 OR HIGHER, DRIVER BOARD 161500/02 OR HIGHER) -REPLACE CONTROL BOARD IF PROBLEM PERSISTS AFTER THE CUSTOMER PREFORMED A RESET THE PROBLEM DIDNT REAPPER THE BLOWER TESTS WAS PREFORMED O.K . CAN WE SEND THIS UNIT BACK TO WORK ? BR LIOR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405876 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown