BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESTREAM DRX-EVOLUTION

    MDR report key: 2269415 · Received September 26, 2011

    Report

    Report Number
    1317307-2011-00003
    Event Type
    Other
    Date Received
    September 26, 2011
    Date of Event
    August 25, 2011
    Report Date
    September 23, 2011
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    PMA / PMN Number
    K091889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TRAINING FOR THE CARESTREAM DRX-EVOLUTION EMPHASIZES THAT THE BUCKY AND WALL STAND ARE NOT TO BE USED FOR PT SUPPORT. THE "DRX-EVOLUTION SAFETY AND REGULATORY INFORMATION" INSTRUCTIONS (DOCUMENT NO. (B)(4)) CONTAIN THE FOLLOWING STATEMENTS: ON PAGE 1-8, "CAUTION: THE WEIGHT LIMIT ON THE WALL STAND BUCKY IS 23 KG (50 LB.) DO NOT EXCEED THIS WEIGHT ON THE BUCKY." ON PAGE 1-9, "USE CAUTION WHEN ROTATING THE WALL STAND BUCKY. KEEP HANDS AND OTHER BODY PARTS AWAY FROM THE MOVING PARTS." "KEEP THE PT AWAY FROM THE BUCKY ASSEMBLY WHEN ROTATING THE BUCKY, OR WHEN MOVING IT HORIZONTALLY OR VERTICALLY."

    Description of Event or Problem · 1

    PT WAS HOLDING ONTO THE WALL STAND BUCKY AND THE BUCKY ROTATED. THE PT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESTREAM DRX-EVOLUTION DR SYSTEM KPR CARESTREAM HEALTH, INC. VX3733-SYS

    Patients

    Seq Age Sex Outcome Treatment
    1