BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMNO TRAC (OMEGA)

    MDR report key: 213578 · Received March 9, 1999

    Report

    Report Number
    2050001-1999-00036
    Event Type
    Malfunction
    Date Received
    March 9, 1999
    Date of Event
    February 16, 1999
    Report Date
    March 9, 1999
    Manufacturer
    SENSORMEDICS CORP.
    Product Code
    LEL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE CONDUCTING AN ANALYSIS OF A SLEEPING PT, IT WAS REPORTED THAT THE AMPSTAR HEADBOX WAS SMOKING AND WIRES WERE BURNING. THERE WERE NO INJURIES TO ANYONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOMNO TRAC (OMEGA) SLEEP DISORDER TESTING SYSTEM LEL SENSORMEDICS CORP. 4250 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN