BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 970SE

    MDR report key: 2857541 · Received November 16, 2012

    Report

    Report Number
    3007056120-2012-00023
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    PHILLIPS RESPIRONICS, INC.
    Product Code
    NPF
    PMA / PMN Number
    K892006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SMART MONITOR 970SE INFANT APNEA DEVICE HAS BEEN OBSOLETE SINCE SEPTEMBER OF 2005. THE HOME OPERATOR'S MANUAL INSTRUCTS THE OPERATOR TO PERFORM THE FUNCTIONAL SELF-TEST AT LEAST ONCE A WEEK, WHEN A LEAD WIRE IS CHANGED OR WHEN THE PT CABLE IS CHANGED. THE FUNCTIONAL SELF-TEST IS A USER-PERFORMED TEST TO VERIFY SMART MONITOR, PT CABLE, AND LEAD WIRES ARE FUNCTIONING PROPERLY. THE HOME OPERATOR'S MANUAL ALSO CAUTIONS THE USER THAT THE SMART MONITOR'S LIGHTS AND ALARMS SHOULD BEHAVE AS DESCRIBED IN THE SELF-TEST. IF THEY DON'T, CONTACT YOUR DEALER. THE CUSTOMER WAS INFORMED BY LETTER OF THE PRODUCTS OBSOLESCE AND THAT THE DEVICE WOULD NOT BE REPAIRED. ADDITIONALLY, THE LETTER INSTRUCTS THE CUSTOMER TO RETURN ANY DEVICES ASSOCIATED WITH PT HARM OR ALARM FAILURE. THE CUSTOMER HAS CHOSEN NOT TO RETURN THE DEVICE. DURING F/U CORRESPONDENCE, AN ADDITIONAL REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR FAILURE INVESTIGATION. NO EQUIPMENT HAS BEEN RETURNED FOR EVAL. THE CUSTOMER'S COMPLAINT ALLEGATION HAS NOT BEEN SUBSTANTIATED. QA HAS DETERMINED THAT ALL NECESSARY REPLIES TO THE CUSTOMER HAVE BEEN COMPLETED AND ARE DOCUMENTED IN THE COMPLAINT RECORD. BASED ON THE AVAILABLE INFO IT IS CONCLUDED THAT NO FURTHER INVESTIGATION INTO THE ALLEGED COMPLAINT CAN TAKE PLACE. IF THE DEVICE IS RETURNED FOR INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED AN ALARM FAILURE ASSOCIATED WITH A SMART MONITOR 970SE INFANT APNEA DEVICE. THE DEVICE WAS NOT IN USE AT THE TIME OF THE REPORTED FAILURE, THERE IS NO PT HARM. THE FAILURE WAS RECORDED DURING THE FUNCTIONAL SELF-TESTING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART MONITOR 970SE APNEA MONITOR NPF PHILLIPS RESPIRONICS, INC. 970SE

    Patients

    Seq Age Sex Outcome Treatment
    1