BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18129839 · Received November 14, 2023

    Report

    Report Number
    3001421318-2023-27786
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    July 8, 2020
    Report Date
    November 8, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K193228
    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 MORE THAN 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 EVENT MAY LEAD TO A DELAY OF THE PROCEDURE AS THE PROCEDURE MUST BE RE-PLANNED OR COMPLETED USING AN ALTERNATIVE MEANS OF VENTILATION. 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 USED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOGS SHOW HIGH RATES AND SMALL TIDAL VOLUMES, THIS MIGHT HAVE SEVERAL REASONS, ALSO LEAKAGE, BUT ALSO CIRCUIT RESISTANCE COMPENSATION. THE EVENT ALSO MIGHT HAVE CAUSED BY INTERACTION WITH THE PATIENT. THE TECHNICIAN SUBJECTED THE DEVICE TO A FUNCTIONAL TEST AND PERFORMED THE SERVICE SOFTWARE TESTS. NO ISSUES WERE FOUND. THE VENTILATOR WORKED PROPERLY AND WAS RETURNED TO PATIENT USE. THERE WAS NO PATIENT OR USER HARM REPORTED. HAMILTON FM 653570 REV. 01 MEDICAL PAGE 5 OF 6 INVESTIGATION REPORT (REMEDIATION) CONFIDENTIAL COMPLAINT (B)(4).

    Description of Event or Problem · 0

    CONSISTENT AUTO CYCLING IN NEO MODE ON THE G5 WITH THE H900 AND THE INFANT DUAL LIMB VENTILATION CIRCUIT 260185 COMPACT FLASH DRIVES BEING SENT TO BONADUZ APVCMV & P-CMV VT 5/ RATE 40-50, I TIME .3-5/ FLOW TRIGGER 0.5/ PEEP 5. IF THEY INCREASE FT TO 0.9 - DECREASES AUTO-CYCLING BUT DOESN'T ELIMINATE. IF THEY INCREASE FT TO 1.0 AND ABOVE SEEMED TO ELIMINATE- NOT AN ACCEPTABLE SOLUTION. THEY CHANGED TO P-CMV- NO DIFFERENCE IN AUTO CYCLING. P-SIMV AND APV SIMV- AUTO-CYCLING PRESENT BUT ONLY AFTER MANDATORY TIME-CYCLED BREATHS. ADJUSTED THE COMPLIANCE OF THE TEST LUNG- NO CHANGE. THERE WAS A VISIBLE 'BOUNCE' SEEN ON THE FLOW SCALAR IMMEDIATELY AFTER THE BREATH- VALUE APPEARED TO BE 2.2 LPM RIGHT BEFORE AUTO-TRIGGER (FT 0.5). CHANGED THE WYE PIECE TO AN F&P WYE PIECE WITH H900 CIRCUIT- NO DIFFERENCE. BYPASSED HUMIDIFIER CHAMBER-DURING THEIR PREVIOUS TROUBLE-SHOOTING AND INVESTIGATIONS THAT WHEN THEY BYPASSED THE WATER CHAMBER THE AUTO-CYCLING CONTINUED. DROPPED PEEP TO ZERO, AUTO-CYCLING RESOLVED EACH TIME WE DID THIS BUT NOT AN ACCEPTABLE FIX . CHANGED TO PRESSURE TRIGGER < 1 CMH20- AUTO-CYCLING CONTINUED: 1CMH20 - NO AUTO-CYCLING. WHEN SWITCHING BACK TO USING THE FISCHER & PAYKEL MR850 HUMIDIFIER AND F&P INFANT CIRCUIT - NO ISSUE WITH REGARDS TO AUTO-CYCLING ON THE G5 DURING VENTILATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041790 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown