BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    970S SMARTMONITOR

    MDR report key: 492509 · Received October 24, 2003

    Report

    Report Number
    2518422-2003-00048
    Event Type
    Malfunction
    Date Received
    October 24, 2003
    Date of Event
    September 24, 2003
    Report Date
    September 24, 2003
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNIT WAS RETURNED FOR SERVICE UNRELATED TO THIS FAILURE. DURING REPAIR EVALUATION IT WAS DISCOVERED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT OR REPORTED PATIENT HARM. 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