BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANOSCAN 360

    MDR report key: 1941468 · Received December 13, 2010

    Report

    Report Number
    1941468
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 13, 2010
    Manufacturer
    SIERRA SCIENTIFIC
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    AFTER ENTERING THE PT INFORMATION INTO THE NEW MOTILITY COMPUTER, FOLLOWING PROTOCOL, THE CORRECT PROMPTS WERE NOT AVAILABLE WHEN THE PROCEDURE STARTED. THE MOTILITY CATHETER WAS PLACED DURING AN UPPER ENDOSCOPY. THE STUDY WAS STARTED BUT THE USUAL PROMPTS WERE NOT AVAILABLE. THE STUDY WAS CONTINUED BECAUSE IT WAS RECORDING. WE WERE ABLE TO END AND SAVE AS IS NORMALLY DONE. THE PT INFO WAS NOT FOUND IN THE ANALYSIS PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANOSCAN 360 MOTILITY COMPUTER FFX SIERRA SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR