BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2 PS

    MDR report key: 3458642 · Received October 11, 2013

    Report

    Report Number
    3007056120-2013-00017
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Report Date
    September 3, 2013
    Manufacturer
    PHILIPS RESPIRONICS - CHMV
    Product Code
    NPF
    PMA / PMN Number
    K032403
    Removal / Correction Number
    NO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K): K061256. (B)(4). THE MFR REC'D THE DEVICE FOR EVAL AND THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS CONFIRMED BY THE SERVICE TECHNICIAN. THE UNIT WAS FOUND TO BE ALARMING AND THE DISPLAY'S LED'S FLASHING DUE TO THE AAA BATTERIES MISSING AND THE BATTERY PACK BEING DEPLETED. AN ADD'L FINDING UNRELATED TO THE CUSTOMER COMPLAINT WAS ALSO RECORDED DURING THE EVAL AND ASSOCIATED WITH ONE OF THE TWO ALARMS HAVING A LOW AUDIBLE VOLUME. THE AAA BATTERIES AND THE ALARM PCA WERE REPLACED TO CORRECT THE RECORDED ISSUES. THE ALARM PCA WAS FORWARDED TO SUPPLIER QUALITY ENGINEERING FOR FURTHER INVESTIGATION. THE PRIMARY ALARM WAS FOUND TO OPERATE AND ALARM TO SPECIFICATION. THE SMARTMONITOR 2PS IS INTENDED FOR USE IN THE CONTINOUS MONITORING OF RESPIRATION, HEART RATE AND SPO2 LEVELS OF INFANT, PEDIATRIC, AND ADULT PTS. IT DETECTS AND ALARMS FOR PERIODS OF HIGH OR LOW HEART RATE, HIGH OR LOW BREATH RATE, AND HIGH OR LOW SATURATION. WHEN USED AS AN INFANT MONITOR IT IS INTENDED FOR USE IN A HOME OR HOSPITAL OR HOSPITAL ENVIRONMENT. FOR INFANTS ONLY, IT MONITORS AND ALARMS FOR CENTRAL APNEAS. WHEN USED AS A PEDIATRIC OR ADULT MONITOR, IT IS INTENDED FOR USE IN A HOSPITAL ENVIRONMENT. BASED ON A COMPLETE REVIEW OF THE AVAILABLE INFO, QUALITY ASSURANCE HAS DETERMINED THAT NONE OF ISSUES RECORDED DURING THE SERVICING OF THE DEVICE PRESENTS AN INCREASED RISK TO PT SAFETY. HOWEVER THE FAULTY SECONDARY ALARM ISSUE IS BEING REPORTED DUE TO THE CRITICAL NATURE OF THE COMPONENT. THE RESULTS OF THE INVESTIGATION WILL BE DETAILED IN A F/U ADD'L INFO REPORT ONCE IT HAS BEEN CONCLUDED.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) REC'D A SMARTMONITOR 2 PS (PROFESSIONAL SERIES) DEVICE BACK FROM A (B)(4) SUPPLIER STATING THAT THE DISPLAY WAS NOT WORKING AND THAT THE DEVICE WAS ALARMING CONTINUOUSLY. THERE IS NO ALLEGATION OF PT HARM. THE DEVICE WAS REPORTEDLY IN USE AT THE TIME OF THE ALLEGED FAILURE AND APPROPRIATELY NOTIFIED THE CAREGIVER OF A POTENTIAL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524633 SMART MONITOR 2 PS NPF PHILIPS RESPIRONICS - CHMV 1014557

    Patients

    Seq Age Sex Outcome Treatment
    1