BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2 PS

    MDR report key: 4330095 · Received August 26, 2014

    Report

    Report Number
    1218950-2014-07405
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Report Date
    August 1, 2014
    Manufacturer
    PHILIPS RESPIRONICS -CHMV
    Product Code
    NPF
    PMA / PMN Number
    K032403, K06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PMA 510(K): K032403, K061256.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A COMPLAINT OF A BATTERY DRAINING TOO QUICKLY. THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT OBSERVED DURING THE REPAIR EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CTR, HOWEVER, A FINDING OF "FAULTY ALARM MODULE" NOT RELATED TO THE CUSTOMER'S COMPLAINT WAS OBSERVED. THE SECONDARY ALARM DID ALARM AS EXPECTED BUT WE ARE REPORTING THE ON THE FAULTY ALARM MODULE PREVENTATIVELY. THE MODULE WILL BE SENT TO THE SUPPLIER AND A F/U REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517559 SMART MONITOR 2 PS NPF NPF PHILIPS RESPIRONICS -CHMV 1014557

    Patients

    Seq Age Sex Outcome Treatment
    1