BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18214757 · Received November 28, 2023

    Report

    Report Number
    3001421318-2023-26005
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 10, 2020
    Report Date
    November 28, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K153046
    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: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED 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. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. THE ISSUE WAS CAUSED BY A DEFECTIVE PART. IN CONSEQUENCE THE PART WAS REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    THE FAILURE IS SOMEWHAT INTERMITTENT. DAVE WAS ABLE TO GO THROUGH A SERVICE SOFTWARE CALIBRATION AND WAS IN SYSTEM TEST WHEN IF FIRST ACTED UP. REPEATING TESTS IN ADJ/CAL THEN COMP TEST NOW FAILED. PAW AND QAW WERE THE "OFF VALUES" IN THE SYSTEM TEST. INITIALLY TRYING A NEW CIRCUIT FIXED THE FAILURES IN ADJ CAL / TEST COMP, BUT WHEN HE GOT TO SYSTEM TEST THE SAME FAILURES STARTED COMING UP. TF 231001 OCCURRED AT THE HIGHER FLOWS AND PRESSURES IN SYSTEM TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599897 HAMILTON MEDICAL AG HAMILTON-MR1 CBK HAMILTON MEDICAL AG HAMILTON-MR1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown