BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2 PS

    MDR report key: 3802321 · Received February 21, 2014

    Report

    Report Number
    3007056120-2014-00008
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 23, 2014
    Manufacturer
    PHILLIPS RESPIRONICS - CHMV
    Product Code
    FLS
    PMA / PMN Number
    K032403
    Removal / Correction Number
    NO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION. THE UNIT WILL BE EVALUATED ONCE IT HAS BEEN RECEIVED AND A FOLLOW-UP ADDITIONAL INFORMATION REPORT WILL BE FILED DETAILING THE FINDINGS. PMA/510(K)# K061256.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM (B)(6) STATING THAT A SMARTMONITOR 2 PROFESSIONAL SERIES (PS) DEVICE WAS "NOT PASSING ONE OF THE SENSITIVITY POINTS". THE SMARTMONITOR DEVICES WAS REPORTEDLY BEING TESTED AT THE TIME THE ALLEGED FAILURE AND NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108925 SMARTMONITOR 2 PS FLS PHILLIPS RESPIRONICS - CHMV 1014557

    Patients

    Seq Age Sex Outcome Treatment
    1