BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17314640 · Received July 13, 2023

    Report

    Report Number
    3001421318-2023-15874
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    March 7, 2022
    Report Date
    July 13, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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" WAS SOLVED BY PREVENTIVE MAINTENANCE. NO INFORMATION REGARDING THE INDIVIDUAL TASKS TAKEN IS AVAILABLE. MOST LIKELY THIS ISSUE WAS SOLVED BY THE CALIBRATION OF THE 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

    HIGH OXYGEN LEAK TEST FAILED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170983 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown