BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18718888 · Received February 16, 2024

    Report

    Report Number
    3001421318-2023-42041
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    November 30, 2022
    Report Date
    February 15, 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 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 ESM BOARD PN-161658 IN CONSEQUENCE THE CORRECTION TO REPLACE THE ESM BOARD RESOLVED THE ISSUE. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    DEAR MILAD, A CUSTOMER HAD A PROBLEM WITH A C1 UNIT: ALERTED ON TF283005 TF249011. WE COULDN'T REPRODUCED THE PROBLEM. PLEASE ADVISE HILEL YAFE SC2202225 B.R. ILAN OFMAN BEPEX LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910360 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown