BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KION

    MDR report key: 1912472 · Received November 9, 2010

    Report

    Report Number
    8010042-2010-00253
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K024213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE ANESTHESIA MACHINE WAS BEING USED ON A PT, A HIGHER PRESSURE THAN SET WAS GENERATED. IMPORTER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KION BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1