BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS INF ADH SENSOR

    MDR report key: 4913364 · Received July 10, 2015

    Report

    Report Number
    2031172-2015-00918
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K083719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SIGNAL WAS NOT DISPLAYED ON THE MONITOR EXCEPT FOR A FLAT PLETH WAVEFORM AND NO SPO2. THE CUSTOMER ALSO REPORTED THAT NO SPO2 VALUE DISPLAYED AND THE PLETH WAVEFORM REMAINED FLAT FOR GREATER THAN 10 SECONDS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIGNAL WAS NOT DISPLAYED ON THE MONITOR EXCEPT FOR A FLAT PLETH WAVEFORM AND NO SPO2. THE CUSTOMER ALSO REPORTED THAT NO SPO2 VALUE DISPLAYED AND THE PLETH WAVEFORM REMAINED FLAT FOR GREATER THAN 10 SECONDS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIGNAL WAS NOT DISPLAYED ON THE MONITOR EXCEPT FOR A FLAT PLETH WAVEFORM AND NO SPO2 VALUE FOR GREATER THAN 20 SECONDS WHILE USING THE DEVICE. CUSTOMER ALSO REPORTED THAT THE SPO2 VALUE DISPLAYED AND PLETH WAVEFORM REMAINED FLAT FOR GREATER THAN 20 SECONDS. NO KNOWN IMPACT OR CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448395 LNCS INF ADH SENSOR OXIMETER DQA MASIMO CORPORATION 2690 K15A11

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR LNC GE CABLE