BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-H.E.L.P.

    MDR report key: 4058519 · Received August 12, 2014

    Report

    Report Number
    4058519
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    WHILE GETTING READY FOR CASE, SURGICAL TECH TRIED TURNING ON D-HELP WARMER AND IT WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480475 D-H.E.L.P. DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR GCJ COVIDIEN LP 22210 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR