BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    970S SMARTMONITOR

    MDR report key: 475771 · Received July 31, 2003

    Report

    Report Number
    2518422-2003-00031
    Event Type
    Malfunction
    Date Received
    July 31, 2003
    Date of Event
    July 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT THE UNIT DID NOT ALARM "WHEN TURNED OFF INCORRECTLY" (THE SIBLING ALARM WAS NOT FUNCTIONING TO SPECIFICATION). THE MALFUNCTION WAS IDENTIFIED AFTER THE CHECK OUT PROCEDURE BY THE CUSTOMER. THERE WAS NO PT INVOLVEMENT OR HARM. A REPAIR EVALUATION WAS PERFORMED AND IT WAS CONFIRMED THAT THE UNIT'S SIBLING ALARM WAS NON-FUNCTIONAL. A CAPACITOR ON THE CPU BOARD WAS REPLACED TO CORRECT THE PROBLEM. ALL OTHER ALARMS; (APNEA, HIGH-HEART RATE, LOW HEART-RATE, ETC.) WERE FUNCTIONING CORRECTLY. THERE WAS NO PT HARM. NO FURTHER ACTION PLANNED AT THIS TIME.

    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