BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8, HORIZONTAL

    MDR report key: 4913386 · Received July 10, 2015

    Report

    Report Number
    2031172-2015-00917
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVAL IT WAS FOUND THAT WHEN THE DEVICE IS TAPPED OR BUMPED, THE AC POWER LED SOMETIMES SHUTS OFF INDICATING AN AC POWER INTERRUPTION. ON A FULLY CHARGED BATTERY, THE DEVICE SWITCHES TO BATTERY POWER WITHOUT INTERRUPTION IN THE DISPLAY. IF THE BATTERY IS DISCONNECTED OR COMPLETELY DISCHARGED, THEN IT MAY INTERRUPT THE DISPLAY. CRACKED SOLDER JOINTS WERE FOUND ON THE POWER SUPPLY MODULE WHICH MAY INTERRUPT AC POWER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THE DISPLAY IS ERRATIC AND HAS A DAMAGED AC MODULE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO PT. ADDITIONAL INFO RECEIVED INDICATED THAT READOUT DISPLAY WOULD CUT IN AND OUT, AS IF THERE WAS A POWER LOSS EVEN THOUGH IT WAS PLUGGED IN AND HAD BATTERY CHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448354 RAD-8, HORIZONTAL OXIMETER DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1