BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 15721041 · Received November 3, 2022

    Report

    Report Number
    3001421318-2022-00043
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    September 29, 2022
    Report Date
    March 27, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION OF CER (B)(4) : HAMILTON MEDICAL AG HAS NOT YET INVESTIGATED THE CASE BASED. HAMILTON MEDICAL IS WAITING FOR THE DEVICE TO INVESTIGATE THE CLAIMED ISSUE " DEVICE WENT IN STANDBY WITHOUT OPERATOR'S INTERACTION" IT WAS CLAIMED AN AMBIENT MODE (VENTILATION STOP), BUT IT IS NOT YET CONFIRMED. NO PATIENT WAS HARMED. THE INVESTIGATION SHOWED THAT A HARDWARE RELATED ISSUE LED TO THE HAMILTON-C6 GOING INTO "AMBIENT STATE". DURING "AMBIENT STATE" THE INSPIRATORY CHANNEL AND EXPIRATORYVALVES ARE OPENED, LETTING THE PATIENT BREATHE ROOM AIR UNASSISTED. CONCLUSION: INVESTIGATION - PENDING. CAUSE: INVESTIGATION - PENDING.

    Additional Manufacturer Narrative · 0

    CONCLUSION OF CER (B)(4) : FROM THE INFORMATION RECEIVED AND THE ANALYSIS PERFORMED REGARDING THIS CASE, THE ROOT CAUSE OF THIS EVENT WAS DUE TO A USE ERROR. THE HAMILTON-C6 WORKED AS INTENDED. THE LOG FILE ANALYSIS INDICATE THAT THE VENTILATOR WAS PUT MANUALLY INTO STANDBY MODE. TWO INDEPENDENT STEPS ARE REQUIRED TO GET INTO STANDBY MODE: 1. PRESS THE HARDKEY ON THE INTERACTION PANEL, AND 2. CONFIRM WITH THE TOUCHSCREEN OR 1. PRESS THE HARDKEY ON THE VENTILATOR UNIT, AND 2. CONFIRM WITH THE TOUCHSCREEN. CONCLUSION: THE VENTILATOR WORKED AS INTENDED AND THE USER PUT THE VENTILATIOR INTO STANDBY MODE MANUALLY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DESCRIPTION FROM HOSPITAL: AT (B)(6) HOSPITAL THE DEVICE HAS ENTERED AMBIENT STATE WHILE VENTILATING A PATIENT. FIRST INFORMATION HAS IT THAT THE PATIENT WAS NOT INJURED. ORIGINAL CUSTOMER COMPLAINT: THE DEVICE SWITCHED TO AMBIENT MODE DURING VENTILATION.SOME TECHNICAL FAULTS WERE LOGGED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ORIGINAL CUSTOMER COMPLAINT: IL CLIENTE DICE CHE IERI ALLE 14.17 IL VENTILATORE È ANDATO IN STAND BY DA SOLO. TRANSLATED WITH WWW.DEEPL.COM: THE CLIENT SAYS THAT YESTERDAY AT 2:17 P.M. THE FAN WENT INTO STANDBY BY ITSELF. *NOTE THE COMPLAINT DESCRIPTION OF THE INTIAL MDR WAS A COPY AND PASTE ERROR AND WAS MISTAKELY OVERTOOK FROM A TEMPLATE. AS WELL THE SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788963 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown