BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONIN 8500

    MDR report key: 558640 · Received November 15, 2004

    Report

    Report Number
    558640
    Event Type
    Malfunction
    Date Received
    November 15, 2004
    Date of Event
    November 8, 2004
    Report Date
    November 15, 2004
    Manufacturer
    NONIN MEDICAL INC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    A NONIN 8500 PULSE OXIMETER WAS BROUGHT TO THE BIOMED DEPT IN A NON-OPERATIONAL STATE. THE BIOMED TECH FOUND THAT THE BATTERIES HAD BEEN INSTALLED INCORRECTLY. AFTER INSTALLING NEW BATTERIES THE UNIT WAS STILL NON-FUNTIONAL AT WHICH TIME THE TECHNICIAN OPENED THE UNIT TO FIND THE INTERNAL BATTERY CONTACTS HAD MELTED INTO THE CASE AND WERE NO LONGER ABLE TO MAKE CONTACT WITH THE BATTERY TERMINALS. THERE WAS ALSO DISCOLORATION OF THE CASE INDICATING EXTREME HEAT.FOLLOW UP TESTING REVEALS: BIOMED TESTED SAFETY DIODE USING TRACKER DEVICE UNIT WAS OK. DEPT THEN REPLACED PULSE OXIMETER BACK AND BATTERY CONTACTS AND RETURNED UNIT TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONIN 8500 HAND HELD PULSE OXIMETER DQA NONIN MEDICAL INC 8500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *