BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA CONTROL UNIT

    MDR report key: 800332 · Received December 20, 2006

    Report

    Report Number
    9616240-2006-00508
    Event Type
    Malfunction
    Date Received
    December 20, 2006
    Date of Event
    November 20, 2006
    Report Date
    November 20, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    PMA / PMN Number
    k010805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY NOR MEDICAL INTERVENTION INFO WAS REPORTED. FACILITY'S TECHNICIAN INSPECTED THE MACHINE AND NO PROBLEM WAS FOUND. THE SAFETY ALERT TRAINING HAS NOT BEEN PERFORMED YET IN THIS FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MACHINE REMOVED LESS THAN IT WAS SET FOR. THE MACHINE WAS SET TO REMOVE 70ML/H.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other