BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2

    MDR report key: 3831975 · Received March 7, 2014

    Report

    Report Number
    3007056120-2014-00009
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    February 6, 2014
    Manufacturer
    PHILIPS RESPIRONICS -CHMV
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Removal / Correction Number
    NO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SMARTMONITOR 2 DEVICE IS DESIGNED TO MONITOR RESPIRATION AND HEART RATE. UPON DETECTION OF ABNORMAL EVENTS, SMARTMONITOR 2 ALERTS THE CAREGIVER VIA BOTH VISUAL AND AUDIBLE ALARMS AND RECORDS THE INFO FOR SUBSEQUENT CLINICAL REVIEW. BASED ON A COMPLETE REVIEW OF THE AVAILABLE INFO IT IS CONCLUDED THAT THE COMPLAINT ALLEGATION COULD NOT BE SUBSTANTIATED. IF THE UNIT IS RETURNED FOR INVESTIGATION OR IF FURTHER INFO IS RECEIVED, AN ADDITIONAL INFO, FOLLOWUP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM (B)(6) STATING THAT A SMART MONITOR 2 INFANT APNEA MONITOR FAILING SIMULATION TEST. THE DEVICE WAS NOT IN PT USE, THE ALLEGED FAILURE WAS RECORDED DURING TESTING. THE DME STATED THAT THE DEVICE HAS NOT YET BEEN SENT IN FOR EVALUATION AND IT IS UNK IF THE DEVICE WILL BE RETURNED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139494 SMARTMONITOR 2 FLS PHILIPS RESPIRONICS -CHMV 4003

    Patients

    Seq Age Sex Outcome Treatment
    1