BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 7045242 · Received November 20, 2017

    Report

    Report Number
    7045242
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    July 5, 2017
    Report Date
    September 21, 2017
    Manufacturer
    SEDECAL USA, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RADPRO DIGITAL MOBILE RADIOGRAPHIC/FLUOROSCOPIC SYSTEM REPORTED NOT TO STAY TURNED ON. THE SYSTEM WAS SERVICED BY BIOMED WHO FOUND THAT THE HARNESS FOR THE BATTERIES BURNT OUT. A NEW CHARGER HARNESS INSTALLED AND TESTED ON THE UNIT. THE UNIT WAS OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826576 SEDECAL SYSTEM, X-RAY, MOBILE IZL SEDECAL USA, INC. SM-40HF-B-D-C

    Patients

    Seq Age Sex Outcome Treatment
    1