BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    970S SMARTMONITOR

    MDR report key: 495074 · Received November 7, 2003

    Report

    Report Number
    2518422-2003-00049
    Event Type
    Malfunction
    Date Received
    November 7, 2003
    Date of Event
    October 8, 2003
    Report Date
    October 8, 2003
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED FOR SERVICE BECAUSE IT FAILED SELF-TESTING AND DID NOT ALARM AS SPECIFIED. THERE WAS NO PT INVOLVEMENT OR REPORTED PT HARM. DURING THE REPAIR EVALUATION IT WAS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THE UNIT HAS BEEN FORWARDED TO ENGINEERING FOR ROOT CAUSE ANALYSIS OF THE ALARM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 970S SMARTMONITOR INFANT/APNEA MONITOR BZQ RESPIRONICS, INC. 970S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA