BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2 PROFESSIONAL SERIES

    MDR report key: 3349136 · Received August 23, 2013

    Report

    Report Number
    3007056120-2013-00011
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Manufacturer
    PHILIPS RESPIRONICS - CHMV
    Product Code
    FLS
    PMA / PMN Number
    K032403
    Removal / Correction Number
    NO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION FOR 510(K): K061256. THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. SMARTMONITOR2 IS DESIGNED TO MONITOR AND RECORD PT'S BREATHING (RESPIRATION), HEART (CARDIAC) ACTIVITY. THE MONITOR ALERTS YOU IF ANY OF THESE ACTIVITIES EXCEEDS THE LIMITS PRESCRIBED BY THE PHYSICIAN. PT ALARM LIMITS ARE SET BY THE HEALTH CARE PROFESSIONAL BEFORE THE SMARTMONITOR2 IS DELIVERED TO THE PT. DURING MONITORING, WHEN THE PT'S BREATHING EFFORT AND/OR HEART ACTIVITY ARE NOT WITHIN THESE SET BOUNDARIES, AN INDICATOR LIGHT COMES ON AND AN ALARM SOUNDS. A FOLLOW-UP REPORT WILL BE FILED DETAILING THE INVESTIGATION CONCLUSIONS ONCE THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT AN INFANT APNEA MONITOR WAS NOT PICKING UP HEART RATE AND RESPIRATORY RATE. THE PRODUCT WAS REPORTEDLY IN USE AT THE TIME OF THE REPORTED EVENT. THERE IS NO ALLEGATION OF PT HARM. HOWEVER, IT IS NOT KNOWN IF THE DEVICE ALARMED AT THE TIME OF THE REPORTED FAILURE TO NOTIFY THE CAREGIVER OF A POTENTIAL EVENT. THE DME HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION AND STATED THAT THE DEVICE WAS PUT THROUGH AND PASSED THE DEVICE CHECKOUT VERIFICATION PROCEDURE PRIOR TO BEING PUT INTO PT USE BUT THAT NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME IN RELATION TO WHETHER OR NOT THE DEVICE ALARMED AT THE TIME OF THE REPORTED EVENT. THIS REPORT IS BEING FILED DUE TO THE FACT THAT IT IS UNKNOWN WHETHER OR NOT THE UNIT ALARMED APPROPRIATELY FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410378 SMARTMONITOR 2 PROFESSIONAL SERIES APNEA MONITOR FLS PHILIPS RESPIRONICS - CHMV 1030271

    Patients

    Seq Age Sex Outcome Treatment
    1