BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 13479708 · Received February 8, 2022

    Report

    Report Number
    3014766741-2022-00003
    Event Type
    Death
    Date Received
    February 8, 2022
    Date of Event
    January 21, 2022
    Report Date
    March 27, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE FOLLOWING CONCLUSION: ORIGINAL ASSESSMENT FROM (B)(6)2022: DER KUNDE HAT UNS ZURÜCKGEMELDET, DASS ER KEINE WEITEREN INFORMATIONEN MIT UNS TEILEN WERDE. AUFGRUND DER VOM KUNDEN GEMELDETEN INFORMATIONEN UND DER AUSWERTUNG DER LOGFILES, HAT UNSER GERÄT AUFGRUND DES HOCH EINGESTELLTEN DRUCKS IMMER WIEDER MIT EINEM «PRESSURE (HIGH)» ALARM ALARMIERT. UNSER GERÄT HAT ZU JEDEM ZEITPUNKT KORREKT FUNKTIONIERT. AUS DIESEM GRUND GING VON UNSEREM GERÄT KEINE RISIKO AUS (RISK ID: NO_RISK). DER SCHWEREGRAD DES FALLES IST AUFGRUND DER TATSACHE, DASS DER PATIENT VERSTORBEN IST MIT 1 BEWERTET. DA DER DRUCK GEM. LOGFILES NICHT REDUZIERT WURDE UND WILLENTLICH WEITERHIN HOCHGEHALTEN WURDE, IST DIES EIN INDIZ FÜR DEN SCHLECHTEN GESUNDHEITSZUSTAND DES PATIENTEN UND DASS DIE ANWENDER ALLES VERSUCHTEN, DEN PATIENTEN ZURÜCKZUHOLEN/ZU STABILISIEREN. TRANSLATED WITH WWW.DEEPL.COM: THE CUSTOMER REPORTED BACK TO US THAT HE WOULD NOT SHARE ANY FURTHER INFORMATION WITH US. BASED ON THE INFORMATION REPORTED BY THE CUSTOMER AND THE EVALUATION OF THE LOG FILES, OUR DEVICE HAS REPEATEDLY ALERTED WITH A "PRESSURE (HIGH)" ALARM. OUR DEVICE WAS FUNCTIONING CORRECTLY AT ALL TIMES. FOR THIS REASON, THERE WAS NO RISK FROM OUR DEVICE (RISK ID: NO_RISK). THE SEVERITY OF THE CASE IS RATED 1 DUE TO THE FACT THAT THE PATIENT DIED. SINCE THE PRESSURE WAS NOT REDUCED ACCORDING TO THE LOG FILES AND WAS DELIBERATELY KEPT HIGH, THIS IS AN INDICATION OF THE PATIENT'S POOR STATE OF HEALTH AND THAT THE USERS TRIED EVERYTHING TO BRING THE PATIENT BACK/STABILIZE HIM. TRANSLATED WITH WWW.DEEPL.COM/TRANSLATOR (FREE VERSION). CONCLUSION: CUSTOMER DOES NOT WISH TO SEND THE VENTILATOR IN, IN FACT THEY HAVE CANCELLED THE RGA. THEY WILL NOT BE ANSWERING THE QUESTIONS YOU ASKED IN PREVIOUS EMAILS. PATIENT HARM: PATIENT EXPIRED, CAUSES UNKNOWN -> AFTER INVESTIGATION, NOT CAUSED BY THE DEVICE.

    Description of Event or Problem · 0

    RT COMPLAINED OF HIGH PRESSURE ALARMS.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: RT COMPLAINED OF HIGH PRESSURE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551908 HAMILTON MEDICAL AG HAMILTON-C3 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death