BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIDIAGNOST ELEVA

    MDR report key: 2423021 · Received January 18, 2012

    Report

    Report Number
    3003768277-2012-00003
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    November 14, 2011
    Report Date
    January 11, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    KPR
    PMA / PMN Number
    K031535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE NURSE FELL ON LOOSE COVER IN REAR OF MD ELEVA SYSTEM AND WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIDIAGNOST ELEVA KPR, IXL, IXR, JAA KPR PHILIPS HEALTHCARE 708032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other