BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTMONITOR 2

    MDR report key: 3802323 · Received February 21, 2014

    Report

    Report Number
    3007056120-2014-00005
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 22, 2014
    Manufacturer
    PHILLIPS RESPIRONICS - CHMV
    Product Code
    FLS
    PMA / PMN Number
    K011597
    Removal / Correction Number
    NO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER RECEIVED THE DEVICE FOR EVALUATION AND THE CUSTOMER COMPLAINT ALLEGATION WAS CONFIRMED. THE UNIT WAS FOUND TO ALARM TWO TO FIVE SECONDS LATE FOR SIMULATED APNEA EVENTS. THE RECORDED FAILURE WAS ASSOCIATED WITH A FAULTY MAIN PCA. THE CUSTOMER REFUSED THE ESTIMATE FOR REPAIR AND THE DEVICE WAS LABELED AS DEFECTIVE AND RETURNED TO THE CUSTOMER UNREPAIRED. NO ROOT CAUSE ANALYSIS COULD BE CONDUCTED. FURTHER CORRESPONDENCE WITH THE EVALUATING TECHNICIAN HAS CONCLUDED THAT THE RECORDED FAILURE WAS POSSIBLY ASSOCIATED WITH OPERATOR ERROR. THE TECHNICIAN DID NOT UNDERSTAND THE TIME SEQUENCING OF THE TESTING PROCEDURE. WHEN THE DEVICE IS TESTED, A SMALL DELAY OCCURS BETWEEN WHEN AN EVENT BEGINS AND WHEN THE DEVICE RECOGNIZES THE EVENT. THE TECHNICIAN HAS BEEN RETRAINED. 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 INFORMATION FOR SUBSEQUENT CLINICAL REVIEW. THE USER MANUAL STATE THE FOLLOWING USER/OWNER RESPONSIBILITIES. THE RESPIRONICS MONITOR AND ACCESSORIES ARE DESIGNED TO WORK AS DESCRIBED IN THE OPERATOR'S MANUAL. THE USER(S) OF THIS EQUIPMENT SHOULD NOT USE PARTS THAT HAVE FAILED, EXHIBIT EXCESSIVE WEAR, ARE CONTAMINATED OR OTHERWISE INEFFECTIVE. THE MONITOR AND ITS ACCESSORIES SHOULD NOT BE MODIFIED. BASED ON A COMPLETE REVIEW OF THE AVAILABLE INFORMATION, QUALITY ASSURANCE HAS DETERMINED THAT NO FURTHER INVESTIGATION IS APPROPRIATE AT THIS TIME.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT A SMARTMONITOR DEVICE WAS "FAILING THE RECERTIFICATION TEST CASE". THE SMARTMONITOR DEVICE WAS REPORTEDLY NOT IN USE AT THE TIME OF THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108872 SMARTMONITOR 2 FLS PHILLIPS RESPIRONICS - CHMV 4003

    Patients

    Seq Age Sex Outcome Treatment
    1