BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    970S SMART MONITOR

    MDR report key: 530159 · Received March 4, 2004

    Report

    Report Number
    2518422-2004-00011
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Date of Event
    February 3, 2004
    Report Date
    February 3, 2004
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED FOR SVC BECAUSE IT WAS REPORTED BY THE CUSTOMER THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING. THE MALFUNCTION WAS DISCOVERED BY THE SVC TECH DURING TESTING. THERE WAS NO PT INVOLVEMENT OR REPORTED PT HARM. DURING THE REPAIR EVALUATION THE CUSTOMER'S COMPLAINT OF AUDIBLE ALARM FAILURE WAS CONFIRMED. 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 SMART MONITOR INFANT/APNEA MONITOR BZQ RESPIRONICS, INC. 970S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA