BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTMONITOR2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM

    MDR report key: 4345673 · Received December 8, 2014

    Report

    Report Number
    1218950-2014-07412
    Event Type
    Death
    Date Received
    December 8, 2014
    Report Date
    November 18, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    NPF
    PMA / PMN Number
    K011597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 INFORMATION FOR SUBSEQUENT CLINICAL REVIEW. DUE TO A DEATH BEING REPORTED, PHILIPS HEALTHCARE HAS DETERMINED THAT THE REPORTED ISSUE REQUIRED FURTHER INVESTIGATION. PHILIPS HEALTHCARE RECEIVED THE DEVICE FOR EVALUATION. THE UNIT WAS FOUND TO OPERATE AND ALARM APPROPRIATELY FOR SIMULATED EVENTS. NO OBSERVATIONS SUBSTANTIATING A MALFUNCTION OR OTHER OPERATION OUTSIDE OF DESIGN SPECIFICATIONS WERE MADE DURING THE EVALUATION. IT IS CONCLUDED THAT USE OF THE DEVICE DOES NOT PRESENT AN INCREASED RISK TO THE END USER OR PATIENT AND THAT NO CORRECTIVE ACTION OR ADDITIONAL INVESTIGATION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED A CALL FROM LIFEHME INC ON (B)(6) 2014 STATING THAT THEY WOULD LIKE TO HAVE THEIR DEVICE TESTED/CALIBRATED AFTER A PATIENT HAD PASSED AWAY WHILE ON THE DEVICE. THE CUSTOMER STATED THAT THE DEVICE DID ALARM AS EXPECTED DURING THE EVENT AND THAT THERE IS NO ALLEGATION OF THE DEVICE MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789031 SMARTMONITOR2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM NPF PHILIPS MEDICAL SYSTEMS 4003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death