BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDIAGNOST ELEVA WITH FLAT

    MDR report key: 2503126 · Received March 20, 2012

    Report

    Report Number
    3003768277-2012-00025
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Report Date
    February 28, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    KPR
    PMA / PMN Number
    K050151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. EVAL RESULT: INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. EVAL CONCLUSION: INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN SWITCHING BETWEEN THE POSTERIOR/ANTERIOR (PA)/APPLICATION PROFILE (AP) MODES TO PREPARE FOR THE NEXT EXAM, THE C-ARC LOST ITS BALANCE AND FELL QUICKLY DOWN TO THE RIGHT SIDE OF THE TABLE (THE FOOT END). THE ANGULATIONS OF THE C-ARC PASSED THE 45 DEGREES STOP. NO ONE HAS BEEN INJURED BECAUSE NO PATIENT WAS ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIDIAGNOST ELEVA WITH FLAT IZI, KPR KPR PHILIPS HEALTHCARE 708034

    Patients

    Seq Age Sex Outcome Treatment
    1