BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA, REL. 2.3

    MDR report key: 2043223 · Received February 24, 2011

    Report

    Report Number
    3003768277-2011-00218
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    January 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZL
    PMA / PMN Number
    K110435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA "(B)(6) 2011".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE C ARM CUTS OFF BY ITSELF WHILE IN USE IN THE OPERATING ROOM.

    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