BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA, REL. 2

    MDR report key: 2152934 · Received June 17, 2011

    Report

    Report Number
    3003768277-2011-00410
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    May 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K010435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 STATED THAT "THERE IS NO FLUOROSCOPY IMAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV PULSERA, REL. 2 IZL PHILIPS HEALTHCARE 718094

    Patients

    Seq Age Sex Outcome Treatment
    1