BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15993985 · Received December 16, 2022

    Report

    Report Number
    3001421318-2022-00084
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 4, 2022
    Report Date
    December 15, 2022
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION OF CER (B)(4): HAMILTON MEDICAL AG HAS REQUESTED MORE INFORMATION ABOUT THE EVENT. INVESTIGATION IS STILL ONGOING. NO PATIENT WAS HARMED.

    Description of Event or Problem · 0

    TO HAMILTON MEDICAL AG WAS THE FOLLOWING REPORTED: EMAIL FROM CUSTOMER: SO TONIGHT I HAD AN ISSUE WITH THE C3 VENT #: 6023. WHEN WE 1ST PUT THE DONOR ON THIS VENT, HE HAD BEEN HAVING ABOUT A 100ML-150ML VOL LOSS WITH HIS EXHALED VTS. AFTER ALL THE TROUBLE SHOOTING I WAS ABLE TO GET IT TO 50-80ML VOL LOSS. TONIGHT THERE WAS STILL A VOL LOSS, THEN ALL OF A SUDDEN THE VENTILATOR STARTED ALARMING HIGH PEEP AND CIRCUIT DISCONNECT, THEN OF COURSE WOULD DUMP THE VTS. LOOKING AT THE WAVE FORM IT DID LOOK LIKE THERE WAS AUTO PEEPING. AFTER TROUBLESHOOTING THE AUTO PEEP IT STILL CONTINUED TO ALARM THOSE SAME ALARMS. I THEN SUCTIONED, JUST TO SEE AND THERE WERE ANY SECRETIONS. AFTER THAT I ENDED UP CHANGING OUT THE FLOW SENSORS AND BACTERIA FILTERS TO SEE IF THERE WERE ANY OCCLUSIONS THERE WAS IT WAS PICKING UP. NOTHING WORKED!! SO I ENDED UP PLACING HIM ON THE OTHER VENT AND EVERYTHING IS FINE. NORMAL EXHALED VTS, NO AUTO PEEP SHOWING. I DIDN'T KNOW IF THIS ISSUE WAS WORTH YOU COMING OUT AND ASSESSING OR IF YOU THINK IT COULD HAVE JUST BEEN A BAD CIRCUIT FROM THE START. I PUT A NOTE ON THE VENT SAYING TO USE 2ND AS OF NOW AND DIDN'T PULL IT OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734975 HAMILTON MEDICAL AG HAMILTON-C3 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown