BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16633563 · Received March 29, 2023

    Report

    Report Number
    3001421318-2023-00987
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    February 19, 2023
    Report Date
    June 18, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT, BUT IS A RESULT OF AN USER ERROR. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THE VENTILATOR WAS NOT ABLE TO GENERATE NEEDED PRESSURE/VOLUME WHILE ON THE PATIENT. OVER THE COURSE OF TRANSPORT, DESPITE VENTILATION OPTIMIZATION STRATEGIES, THE PATIENT`S ETCO2 CONTINUED TO CLIMB. AN ALTERNATIVE DEVICE WAS NEEDED TO BE USED AND THE PATIENT WAS AT RISK. IN THE EQUIPMENT FAILURE INCIDENT REPORT THE QUESTION: "SHOULD THIS INCIDENT REPORT BE FLAGGED AS A POTENTIAL HARM?" IS ANSWERED WITH "YES". HOWEVER, HAMILTON MEDICAL AG WAS NEVER INFORMED OF ANY PERMANENT HARM TO THE PATIENT. WE ASSUME THAT THERE MAY HAVE BEEN A TEMPORARY INJURY TO THE PATIENT BECAUSE THE OXYGEN SATURATION WAS LOW. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT HAS POTENTIAL TO CAUSE A DELAY IN TREATMENT OR AN INTERVENTION (REPLACEMENT OF THE VENTILATOR), IF IT WERE TO RECUR DURING THE USE WITH A PATIENT. THEREFORE, THE EVENT HAS BEEN DEEMED TO BE A REPORTABLE EVENT. THE ROOT CAUSE WAS DETERMINED TO BE THE USE OF A WRONG EXPIRATORY VALVE. THE VENTILATOR ACCEPTED THE THERAPY AS SET BY THE USER ALTHOUGH A "WRONG EXPIRATORY" VALVE WAS INSERTED. THE DEVICE WAS TESTED BY OUR PARTNER BOMIMED, NO ISSUES WERE FOUND AND THE DEVICE WAS RETURNED TO THE CUSTOMER. NO CORRECTION WAS NEEDED.

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: 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 COULD NOT BE CONFIRMED OR EXCLUDED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED FOR PATIENT VENTILATION. THE ROOT CAUSE COULD NOT BE DETERMINED. IN CONSEQUENCE AN ALTERNATIVE DEVICE WAS USED. PATIENT HARM IS INDICATED BUT COULD NOT BE CONFIRMED. HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: VENTILATOR FAILURE; SPECIFICALLY INABILITY TO GENERATE INSPIRATORY PRESSURE / VOLUME. MACHINE TROUBLE SHOT I TRIALED EXTENSIVELY BY MEDIC MICHAEL CURRY AS WEIL AS MULTIPLE MEMBERS OF SENDING RESPIRATORY THERAPY STAFF MEMBERS. MULTIPLE CIRCUITS TRIALED. MULTIPLE FLOW METERS TRIALED. MULTIPLE VENTILATOR MODES TRIALED. MULTIPLE ACCESSORIES (ACCOUNTING FOR DEAD SPACE) TRIALED. MULTIPLE VENT MODES TRIED. MULTIPLE ETT 35 MM ADAPTORS TRIALED. ALL ATTEMPTS FAILED; ULTIMATELY A DIFFERENT TRANSPORT PLAN ENACTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: VENTILATOR FAILURE; SPECIFICALLY INABILITY TO GENERATE INSPIRATORY PRESSURE / VOLUME. MACHINE TROUBLE SHOT I TRIALLED EXTENSIVELY BY MEDIC MICHAEL CURRY AS WEIL AS MULTIPLE MEMBERS OF SENDING RESPIRATORY THERAPY STAFF MEMBERS. MULTIPLE CIRCUITS TRIALLED. MULTIPLE FLOW METERS TRIALLED. MULTIPLE VENTILATOR MODES TRIALLED. MULTIPLE ACCESSORIES (ACCOUNTING FOR DEAD SPACE) TRIALED. MULTIPLE VENT MODES TRIED. MULTIPLE ETT 35 MM ADAPTORS TRIALLED. ALL ATTEMPTS FAILED; ULTIMATELY A DIFFERENT TRANSPORT PLAN ENACTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: VENTILATOR FAILURE; SPECIFICALLY INABILITY TO GENERATE INSPIRATORY PRESSURE / VOLUME. MACHINE TROUBLE SHOT I TRIALLED EXTENSIVELY BY MEDIC (B)(6) AS WELL AS MULTIPLE MEMBERS OF SENDING RESPIRATORY THERAPY STAFF MEMBERS. MULTIPLE CIRCUITS TRIALLED. MULTIPLE FLOW METERS TRIALLED. MULTIPLE VENTILATOR MODES TRIALLED. MULTIPLE ACCESSORIES (ACCOUNTING FOR DEAD SPACE) TRIALLED. MULTIPLE VENT MODES TRIED. MULTIPLE ETT 35 MM ADAPTORS TRIALLED. ALL ATTEMPTS FAILED; ULTIMATELY A DIFFERENT TRANSPORT PLAN ENACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824257 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown