BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P-SERIES

    MDR report key: 547549 · Received October 6, 2004

    Report

    Report Number
    9613619-2004-00002
    Event Type
    Malfunction
    Date Received
    October 6, 2004
    Date of Event
    September 27, 2004
    Report Date
    October 5, 2004
    Manufacturer
    COMPUMEDICS LIMITED
    Product Code
    LEL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED THAT WHEN THE PT RETURNED THE UNIT THEY INFORMED THE TECHNICIAN THAT THE FINGER PROBE (NONIN PROBE OXIMETER) BURNED THEIR FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P-SERIES SLEEP MONITORING SYSTEM LEL COMPUMEDICS LIMITED 7001-0002-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention