BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS

    MDR report key: 5513425 · Received March 17, 2016

    Report

    Report Number
    MW5060962
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    February 22, 2016
    Report Date
    March 9, 2016
    Manufacturer
    PHILLIPS MEDICAL SYSTEMS - PHILLIPS NORTH AMERICAN CORP.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    TELEMETRY BOX BECAME VERY HOT, NEARLY BURNING THE PATIENT. THE NURSE WAS ABLE TO DISCONTINUE THE USE OF THIS TELEMETRY BOX PRIOR TO THE PATIENT BEING INJURED. THROUGH OUR INVESTIGATION, WE HAVE LEARNED THESE TELEMETRY BOXES HAVE A TENDENCY TO BECOME VERY HOT SO MUCH THEY BEGIN TO SMOKE. DATES OF USE: (B)(6) 2016. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164285 PHILLIPS TELEMETRY TRANSMITTER DRT PHILLIPS MEDICAL SYSTEMS - PHILLIPS NORTH AMERICAN CORP. M4841A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention