BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNOSTREAM20

    MDR report key: 1432884 · Received May 8, 2009

    Report

    Report Number
    8044004-2009-00001
    Event Type
    Malfunction
    Date Received
    May 8, 2009
    Date of Event
    April 22, 2009
    Report Date
    May 7, 2009
    Manufacturer
    ORIDION MEDICAL 1987 LTD.
    Product Code
    DQA
    PMA / PMN Number
    K060065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ORIDION PROMPTLY PERFORMED EMC/EMI/ESD TESTING AT AN ACCREDITED TEST LAB ON 3 ADD'L UNITS IN 2009, WITH THE FOLLOWING FINDINGS: RADIATED EMISSIONS - IN ALL 3 MONITORS WERE PEAKS OUTSIDE THE ALLOWED LIMIT (ACCORDING TO CISPR 11 CLASS A) AT AROUND 100 MHZ AND 500MHZ, EXCEEDING THE LIMIT BY 5DB. THE SOURCE OF THE PEAKS WAS LOCATED IN THE AREA OF THE CPU. ESD - THE USB PORT AND EQUALIZATIONS PIN DIDN'T PASS ESD GUN CONTACT AT 2KV; ALL POINTS ON CHASSIS DIDN'T PASS 6KV. THE SCREEN HAD "FROZEN" AND NOT RESPONDED. IN ORDER TO BRING THE MONITOR BACK TO NORMAL FUNCTION, THE MONITOR WAS DISCONNECTED FROM THE MAINS, THE BATTERY WAS REMOVED AND THEN RETURNED TO THE MONITOR AND UNIT WAS CONNECTED TO MAINS. THE MONITOR THEN FUNCTIONED AS EXPECTED. NO ADVERSE EVENT WAS REPORTED FROM THE FIELD. A REVIEW OF COMPLAINTS RECEIVED SINCE THE DEVICE WAS PLACED ON THE MARKET IN 2006, WAS PERFORMED AND ONE FREEZE EVENT HAD BEEN REPORTED FROM THE FIELD AND THE COMPANY WAS NOT ABLE TO RECONSTRUCT OR DETERMINE THE CAUSE. VARIOUS DEVICE MODELS WITH DIFFERING MANUFACTURING DATES WERE TESTED AND THE MALFUNCTION WAS FOUND ON ALL. THE DEVICE WAS TESTED AS PART OF DESIGN VERIFICATION AND MET ALL REQUIREMENTS AT THAT TIME. THE COMPANY IS CONTINUING TO INVESTIGATE THIS PRODUCT MALFUNCTION AND WILL TAKE APPROPRIATE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    A DEVICE MANUFACTURER WAS TESTING A CAPNOSTREAM20 CAPNOGRAPH/PULSE OXIMETER AND REPORTED FINDING SOME DEVIATIONS FROM THE RADIATED EMISSIONS AND ELECTRO STATIC DISCHARGE REQUIREMENTS DURING LAB TESTING. NO ADVERSE EVENT IN THE FIELD WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPNOSTREAM20 CAPNOGRAPH/PULSE OXIMETER DQA ORIDION MEDICAL 1987 LTD. NA

    Patients

    Seq Age Sex Outcome Treatment
    1