BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17264421 · Received July 6, 2023

    Report

    Report Number
    3001421318-2023-02555
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 6, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: HEPA FILTER DIRTY PRODUCT. DETAILED COMPLAINT AND FAILURE DESCRIPTION: INVOICE# IS (B)(4). FOREIGN OBJECT 1. LOT 00225/21.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787566 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown