BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    970S SMARTMONITOR

    MDR report key: 480030 · Received August 21, 2003

    Report

    Report Number
    2518422-2003-00040
    Event Type
    Malfunction
    Date Received
    August 21, 2003
    Date of Event
    July 22, 2003
    Report Date
    July 22, 2003
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED FROM THE VENDOR THAT THE UNIT'S AUDIBLE ALARM WAS NOT WORKING. THE MALFUNCTION WAS IDENTIFIED DURING THE CHECK OUT PROCEDURE BY THE HEALTH CARE PROVIDER. THERE WAS NO PT INVOLVEMENT OR REPORTED PT HARM. A REPAIR EVALUATION WAS PERFORMED AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. IT WAS DISCOVERED THAT THE ALARM WAS FUNCTIONING INTERMITTENTLY DUE TO AN INCOMPLETE SOLDER JOINT FROM THE ALARM COMPONENT TO THE FRONT DISPLAY BOARD. THE BOARD WAS REPLACED TO CORRECT THE PROBLEM.

    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