BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    970SE-10 HOSPITAL MONITOR

    MDR report key: 523852 · Received February 13, 2004

    Report

    Report Number
    2518422-2004-00008
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Date of Event
    January 15, 2004
    Report Date
    January 15, 2004
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED FOR NON-FUNCTIONAL AUDIBLE ALARMS. THERE WAS NO PT INVOLVEMENT OR REPORTED PT HARM. A REPAIR EVALUATION CONFIRMED THAT THE AUDIBLE ALARMS ARE 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 970SE-10 HOSPITAL MONITOR INFANT/APNEA MONITOR BZQ RESPIRONICS, INC. 970SE-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA