BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA, REL. 2.3

    MDR report key: 2201394 · Received August 3, 2011

    Report

    Report Number
    3003768277-2011-00468
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    July 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K110435
    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 REPORTED THAT NO X-RAY WAS BEING TRIGGERED SEVERAL TIMES. THIS HAPPENED WITHOUT AN ERROR MESSAGE BEING DISPLAYED. THE SYSTEM IS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV PULSERA, REL. 2.3 IZL PHILIPS HEALTHCARE 718095

    Patients

    Seq Age Sex Outcome Treatment
    1