BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMBLETTA PDS / EMBLA

    MDR report key: 315489 · Received January 30, 2001

    Report

    Report Number
    9611753-2001-00001
    Event Type
    Other
    Date Received
    January 30, 2001
    Date of Event
    January 15, 2001
    Report Date
    January 30, 2001
    Manufacturer
    FLAGA HF
    Product Code
    GWQ
    Removal / Correction Number
    F-CA-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING AN UNATTENDED HOME SLEEP STUDY THE EMBLETTA DEVICE HEATED UP. THIS WAS CAUSED BY A BATTERY SHORT-CIRCUITING. THE PATIENT'S SPOUSE OPENED THE BATTERY COMPARTMENT AND TOOK OUT THE BATTERY. THE BATTERY WAS HOT AND THE PT FELT LIKE THEIR FINGER WAS BURNED SO THE PT RAN IT UNDER COLD WATER. WHAT WAS LEFT ON THEIR FINGER WAS A ROUGH AREA WHERE THE PT HAD TOUCHED THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3695 EMBLETTA PDS / EMBLA RESPIRATORY DIAGNOSTIC GWQ FLAGA HF EMBLETTA PDS *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR