BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17684945 · Received September 5, 2023

    Report

    Report Number
    3001421318-2023-11181
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 3, 2022
    Report Date
    September 4, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 MORE THAN ONE YEAR 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 USED. THE ROOT CAUSE WAS DETERMINED TO BE A COMMUNICATION PROBLEM BETWEEN VENTILATOR UNIT (VU) AND INTERACTION PANEL (IP). IN CONSEQUENCE (CORRECTION) THE COMMUNICATION CABLE BETWEEN VU & IP, VU ESM BOARD AND THE IP ESM BOARD WERE REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    GOOD DAY MR. WEIBEL, I WOULD LIKE TO INFORM YOU THAT THERE WAS AN INCIDENT AT CHUV ON (B)(6) 2022: "WHILE TRANSPORTING THE PATIENT TO THE FACILITY (TO PERFORM A COMPUTED TOMOGRAPHY SCAN), THE WHITE SCREEN VENTILATOR TURNED OFF WITHOUT TRIGGERING AN ALARM. THE S1 VENTILATOR WAS SET ASIDE AND ANALYZED BY BIOMEDICAL MAINTENANCE. IN THEIR OPINION, IT WAS A PROBLEM WITH THE RJ45 CABLE DISCONNECTION BETWEEN THE SCREEN AND THE VENTILATOR. PRODUCT NAME : VENTILATOR HAMILTON S1 SERIAL NO: (B)(6) A REPORT WILL BE MADE TO SWISSMEDIC (IT IS A SERIOUS INCIDENT, BUT WITHOUT HARM TO THE PATIENT WHO WAS VENTILATED WITH THE BALLOON DURING THE TIME BETWEEN THE VENTILATOR CHANGE). THANK YOU FOR USING THE ADDRESS (B)(6) IN THE CC OF THIS EMAIL FOR ANY COMMUNICATION RELATED TO THIS INCIDENT. TRANSLATED WITH WWW.DEEPL.COM/TRANSLATOR (FREE VERSION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167140 HAMILTON MEDICAL AG HAMILTON-S1 CBK HAMILTON MEDICAL AG HAMILTON-S1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown