BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIDIAGNOST ELEVA

    MDR report key: 2130677 · Received June 14, 2011

    Report

    Report Number
    3003768277-2011-00408
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 2, 2011
    Report Date
    May 19, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K050151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GROOVES ON THE CPR SUPPORT ACCESSORY FOR THE MULTI DIAGNOST ARE SHARP AND CUT THE RADIOGRAPHERS HAND ON DEMONSTRATION TO A COLLEAGUE FOR TRAINING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIDIAGNOST ELEVA IZI, KPR IZI PHILIPS HEALTHCARE 708037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other