BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17697457 · Received September 7, 2023

    Report

    Report Number
    3001421318-2023-11661
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 16, 2022
    Report Date
    September 6, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K193228
    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 ISSUE IN CER 92930 IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION "CONNECTION PANEL LOST" WHICH LOGS DIFFERENT TFS AND POTENTIALLY SWITCHES TO AMBIENT MODE DURING VENTILATION MAY CAUSE THE VENTILATOR TO BECOME INOPERABLE OR STOP WORKING AS INTENDED. THE ROOT CAUSE OF THE VENTILATOR DEVICE SHOWED MANY TFS IN ONE SINGLE SECOND AND THE DISPLAY \ "PANEL CONNECTION LOST\ " ALARM DURING VENTILATION WAS DUE TO A DEFECTIVE VU AND IP ESM BOARD. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE IT WAS USED FOR TREATMENT OR DIAGNOSIS. THERE WAS NO PATIENT OR USER HARM REPORTED AT ALL BY THE COMPLAINANT WHICH SHOULD HAVE LED TO FURTHER QUESTIONS REGARDING ANY HARM TO THE PATIENT OR USER. SINCE THE COMPLAINT (B)(4) WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. THE ALLEGATION IN 97917 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 THE ISSUE IN 97917 AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    DEAR MILAD, A CUSTOMER HAS A PROBLEM WITH A G5 UNIT: ALRTED ON PANEL CONNECTION LOST. WE REPRODUCED THE PROBLEM. IN ADDITION THE DATE AND HOUR RESETED DURING THE PROBLEM, BUT NOW THE DATE AND HOUR ARE O.K. PLEASE ADVISE, B.R. ILAN OFMAN BEPEX LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201612 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown