BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAD

    MDR report key: 4795275 · Received May 19, 2015

    Report

    Report Number
    9616014-2015-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ARCOMA AB
    Product Code
    KPR
    PMA / PMN Number
    K113855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REASON: MECHANICAL FAILURE, STILL UNDER INVESTIGATION. THE ACTUAL DEVICE IS SCRAPPED (BY THE CUSTOMER) AND CANNOT BE ANALYZED. THE ORIGINAL MFR (SHIN YOUNG FOR M CO.) IS CONTACTED FOR RCA.

    Description of Event or Problem · 1

    THE CUSTOMER HEARD A LOUD NOISE THEN IT (THE STAND) WAS NOT MOVING UP OR DOWN AGAIN. AFTER A WHILE THEY HEARD ANOTHER NOISE AND THE ARM MOVED SLOWLY DOWN. U-ARM FELL 4 INCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324567 PANORAD SYSTEM, X-RAY, STATIONARY KPR ARCOMA AB

    Patients

    Seq Age Sex Outcome Treatment
    1