BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18910832 · Received March 15, 2024

    Report

    Report Number
    3001421318-2023-42260
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    November 7, 2022
    Report Date
    March 14, 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: BASED ON THE AVAILABLE INFORMATION, A ROOT-CAUSE ANALYSIS IS NOT POSSIBLE AS THE "HIGH OXYGEN ALARM" OF THE HAMILTON-C1 COULD NOT BE REPRODUCED. MOST LIKELY THIS ISSUE IS A RESULT OF A DEPLETED/DEFECTIVE O2 CELL (O2 SENSOR). DUE TO THE DEFINED RISK-ID 856 AND THUS SEVERITY 3, THIS ISSUE IS DEEMED TO BE A REPORTABLE EVENT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE.

    Description of Event or Problem · 0

    DEAR MILAD, A CUSTOMER HAD A PROBLEM WITH THIS UNIT: ALERTED ON HIGH O2. WE COULDN'T REPRODUCED THE PROBLEM. PLEASE ADVISE. B.R. ILAN OFMAN BEPEX LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486409 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown