BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 654309 · Received December 16, 2005

    Report

    Report Number
    9616240-2005-00118
    Event Type
    Other
    Date Received
    December 16, 2005
    Report Date
    November 17, 2005
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Removal / Correction Number
    Z-1545-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "COMMAND PATH" MALFUNCTION ALARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA CONTROL UNIT INTENSIVE CARE HEMODIALYSIS KDI GAMBRO DASCO PRISMA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other