BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    970SE SMART MONITOR

    MDR report key: 512541 · Received January 16, 2004

    Report

    Report Number
    2518422-2004-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Date of Event
    December 17, 2003
    Report Date
    December 17, 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

    THE UNIT WAS RETURNED FOR SERVICE BASED ON THE FACT THAT IT WAS "DROPPED" BY THE CAREGIVER. NO SPECIFIC MALFUNCTION WAS IDENTIFIED BY THE CUSTOMER. DURING THE REPAIR EVALUATION IT WAS DISCOVERED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THERE WAS NO PT INVOLVEMENT OR REPORTED PT 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 970SE SMART MONITOR INFANT/APNEA MONITOR BZQ RESPIRONICS, INC. 970SE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA