BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17369739 · Received July 21, 2023

    Report

    Report Number
    3001421318-2023-20319
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    August 23, 2021
    Report Date
    July 21, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 (B)(6) 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

    RESPIRATORY THERAPIST ENCOUNTERED A HIGH OXYGEN ALARM DURING A PATIENT VENTILATION, THE PATIENT WAS NOT HARMED. DEVICE'S FILES WILL BE EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586172 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown