BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16459795 · Received March 1, 2023

    Report

    Report Number
    3001421318-2023-00398
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    January 18, 2023
    Report Date
    April 2, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CASE IS UNDER INVESTIGATION. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION LED TO AN INOPERABLE VENTILATOR. THE ROOT CAUSE IS A MALFUNCTION OF THE FLOW SENSOR AIR. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. 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. HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THERE IS ONE DEVICE NEED TO REPLACE A QO2 SENSOR, WE INSTALL OUR BRAND NEW STOCK PART ON THE DEVICE, WHEN WE DID THE TSW, THE DEVICE SHOWED 431009. NO PATIENT HARM WAS REPORTED. CLARIFICATION FROM HAMILTON MEDICAL AG: ACCORDING TO THE EVENT LOG THE DEVICE SHOWED THE FIRST HIGH PRIORITY ALARM TE 231013 (QO2 DEFECT) ON (B)(6) 2023 17:29:26. THE USER THEN CONTINUED USING THE DEVICE ALTHOUGH THE USER MANUAL SUGGESTS TO REMOVE THE DEVICE FROM THE PATIENT. TE 231013 APPEARED SEVERAL TIMES FOR A FEW SECONDS WHILE THE PATIENT WAS VENTILATED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: THERE IS ONE DEVICE NEED TO REPLACE A QO2 SENSOR, WE INSTALL OUR BRAND NEW STOCK PART ON THE DEVICE, WHEN WE DID THE TSW, THE DEVICE SHOWED 431009. NO PATIENT HARM WAS REPORTED. CLARIFICTION FROM HAMILTON MEDICAL AG: ACCORDING TOT HE EVENT LOG THE DEVICE SHOWED THE FIRST HIGH PRIORITY ALARM TE 231013 (QO2 DEFECT) ON (B)(6) 2023 17:29:26. THE USER THEN CONTINUED USING THE DEVICE ALTHOUGH THE USER MANUAL SUGGESTS TO REMOVE THE DEVICE FROM THE PATIENT. TE 231013 APPEARED SEVERAL TIMES FOR A FEW SECONDS WHILE THE PATIENT WAS VENTILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435161 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown