BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18214759 · Received November 28, 2023

    Report

    Report Number
    3001421318-2023-26663
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    September 25, 2020
    Report Date
    November 28, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    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 JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THE ROOT CAUSE CANNOT BE DETERMINED. THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT 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 THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    C1 VENT, S/N (B)(6) - MULTIPLE (3) INSTANCES WITH HIGH PRESSURE ALARMS, CONFIRMED WHEN ANOTHER C1 REPLACED IT - "WAVE FORM LOOKS AWEFUL (STRAIGHT UP, STRAIGHT DOWN) AND PRESSURES READING IN UPPER 40'S. CHANGE VENTS AND PRESSURE IS IN MID 20'S WITH A NICE WAVE FORM" FIRST TIME STARTED OUT AS OXYGEN ALARM ON 100% THEN DROPPED QUICKLY BELOW 90 AND ALARMED, THEN IT WAS HIGH PRESSURE. THE LAST EVENT WAS REPORTED AS HIGH PRESSURE AND PATIENT WAS SWITCHED TO ANOTHER C1 WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599899 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown