BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BV PULSERA

    MDR report key: 1872868 · Received September 29, 2010

    Report

    Report Number
    3003768277-2010-00217
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZL
    PMA / PMN Number
    K110435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE INVESTIGATION REVEALED THAT A DEFECTIVE POWER SUPPLY OF THE IMAGE INTENSIFIER WAS THE CAUSE OF THE IMAGE ISSUES. THE FIELD SERVICE ENGINEER REPLACED THE FAULTY POWER SUPPLY AND THE SYSTEM IS NOW WORKING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE X-RAY IMAGE, GENERATED BY THE BV PULSERA, IS VERY BLURRY AND A DARK RING WOULD OCCASIONALLY FORM AROUND THE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BV PULSERA IZL (MOBILE X-RAY SYSTEM) IZL PHILIPS MEDICAL SYSTEMS 718095 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA