BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHSWITCH REMOTE EXPOSURE SWITCH

    MDR report key: 4156679 · Received July 25, 2014

    Report

    Report Number
    1317307-2014-00011
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 25, 2014
    Manufacturer
    REMOTE TECHNOLOGIES, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IR REMOTE IS NOT A CARESTREAM HEALTH MANUFACTURED PRODUCT. IT IS MANUFACTURED BY REMOTE TECHNOLOGIES, INC. THE DEVICE HAS BEEN SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INFRARED (IR) REMOTE CONTROL INITIATED AN X-RAY EXPOSURE ALTHOUGH THE TECHNOLOGIST DID NOT PRESS THE EXPOSURE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436676 TECHSWITCH REMOTE EXPOSURE SWITCH TECHSWITCH REMOTE EXPOSURE SWITCH IZL REMOTE TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA