BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON PRO 3

    MDR report key: 3784141 · Received April 25, 2014

    Report

    Report Number
    MW5035850
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 24, 2014
    Manufacturer
    RAD PRO
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) AT APPROX 05:45 HRS, WHILE DRIVING THE RADPRO 3 PORTABLE X-RAY UNIT FROM SURGICAL ICU TO CORONARY ICU THE LEFT DRIVE WHEEL LOCKED, CAUSING THE MACHINE TO PIVOT SHARPLY AND QUICKLY TO THE LEFT. THIS CAUSED THE UNIT TO HIT THE HALL WAY WALL CAUSING A HOLE IN THE DRYWALL. AS PER THE OPERATOR (B)(6) RT. SERVICE WAS REQUESTED TO REPAIR DRYWALL AND CLINICAL ENGINEERING WAS NOTIFIED AND THE UNIT WAS REMOVED FROM SERVICE AND TESTED. (B)(4). NO PT RELATED. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252312 CANON PRO 3 PORTABLE X-RAY UNIT IZL RAD PRO SM-40-HF-B-D-C

    Patients

    Seq Age Sex Outcome Treatment
    1