BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18871944 · Received March 10, 2024

    Report

    Report Number
    3001421318-2023-42272
    Event Type
    Malfunction
    Date Received
    March 10, 2024
    Date of Event
    November 4, 2022
    Report Date
    March 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG OVER 1 YEAR AGO, NO ATTEMPT WILL BE MADE TO OBTAIN ADDITIONAL INFORMATION. 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. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS NOT IN USE. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE INSPIRATORY VALVE. THE INSPIRATORY VALVE WAS REPLACED WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    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. JUST WANTED TO GET YOU THOUGHTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177957 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown