BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL

    MDR report key: 4714117 · Received April 16, 2015

    Report

    Report Number
    2031172-2015-00661
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 17, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K040214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA (G5) : 510(K) NUMBER UPDATED TO K040214. THE RETURNED DEVICE WAS EVALUATED. DURING THE TESTING, WHENEVER J3 SWIVEL (SENSOR) CONNECTOR WAS WIGGLED, THE PLETH WAVEFORM WITH SIGNAL QUALITY INDICATOR WENT FLAT MOMENTARILY AND "LOW SIGNAL IQ" MESSAGE WAS DISPLAYED ON THE SCREEN. THE J3 SWIVEL CONNECTOR WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER TEN (10) YEARS WITH NO RELATED ISSUES PRIOR TO THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING THE TESTING, WHENEVER J3 SWIVEL (SENSOR) CONNECTOR WAS WIGGLED, PLETH WAVEFORM WITH SIGNAL QUAL INDICATOR WENT FLAT MOMENTARILY AND "LOW SIGNAL IQ" MESSAGE WAS DISPLAYED ON THE SCREEN. THE J3 SWIVEL CONNECTOR WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A SVC HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER TEN YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIGNAL KEEPS DROPPING WHEN ANY CABLE IS USED. THE CUSTOMER BELIEVES THAT IT IS THE PT CONNECTOR. NO PT INCIDENT REPORTED, AND WILL ENGAGE IN MONITORING. ADD'L INFO REC'D INDICATED THAT THERE WAS NO ALARM OR ERROR MESSAGE. THE ISSUE OCCURRED WHILE A PT WAS BEING MONITORED. NO KNOWN IMPACT OR CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255849 RADICAL OXIMETER DQA MASIMO CORPORATION 1708

    Patients

    Seq Age Sex Outcome Treatment
    1