BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18928146 · Received March 19, 2024

    Report

    Report Number
    3001421318-2023-40514
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 10, 2023
    Report Date
    March 18, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: 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. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR. IN CONSEQUENCE THE USERS WERE RETRAINED. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Description of Event or Problem · 0

    BESCHREIBUNG VOM KUNDEN: DER VORFALL EREIGNETE SICH AM 10.02.2023 MIT EINEM PATIENTEN. IM NIV-MODUS: INSPIRATORISCHE UNTERSTÜTZUNG AUF 8 UND PEEP AUF 5, VERWENDETE MASKE ANGEPASST UND KEIN LECKAGEALARM. 1. PUNKT DAS TIDALVOLUMEN WURDE NICHT ANGEZEIGT. DIE FREQ. STIEG AUF 70, DANN NACH 10-12 S EINE PAUSE MIT NUR 2-3 EIN-/AUSATMUNGEN UND DANN WIEDER AUF 70. DIE BENUTZER HABEN VERSUCHT, DIE FREQ. AUF 0 ZU STELLEN, DA GING ES VON 70 AUF 50 RUNTER. ANSCHLIESSEND SCHALTETEN DIE BENUTZER DEN RESPIRATOR MANUELL AUS UND FÜHRTEN DIE KALIBRIERUNG ERNEUT DURCH, ABER AUCH DANACH TRAT DAS OBEN GENANNTE PROBLEM WIEDER AUF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360890 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown