BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RD SET DCI

    MDR report key: 6341919 · Received February 17, 2017

    Report

    Report Number
    2031172-2017-00231
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 29, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    UDI-DI
    00843997009805
    PMA / PMN Number
    K042536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED SENSOR WAS EVALUATED. NO EXTERNAL PHYSICAL DAMAGE WAS OBSERVED. THE SENSOR FAILED CONTINUITY TESTING DUE TO MULTIPLE BROKEN TRACES INSIDE THE RD15 CONNECTOR CAUSING MULTIPLE OPEN CONNECTIONS. THE SENSOR WAS CONNECTED TO A MONITOR AND WAS UNABLE TO OBTAIN READINGS, THE SENSOR LED DID NOT ILLUMINATE., CORRECTED DATA: MODEL # WAS CORRECTED FROM 4085-9 TO 4050, LOT# WAS CORRECTED FROM 16JVG TO E16JPS, CATALOG # WAS CORRECTED FROM 4085 TO 4050, UDI# CORRECTED FROM (B)(4) TO (B)(4). CORRECTED FROM K051212 TO K042536. CORRECTED FROM 09/09/2016 TO 09/01/2016. CORRECTED FROM A BLANK FIELD TO RD SET GE-12.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERRUPTION OF PATIENT MONITORING AND AN EXTENDED PERIOD OF TIME BEFORE THE SPO2 BEGINS TO READ. PER THE CUSTOMER, WHEN IT DOES BEGIN TO READ, IT STARTS VERY LOW AND THEN TAKES AN EXTENDED TIME TO COME UP TO THE EXPECTED SPO2. THE SPO2 WILL THEN RANDOMLY DROP-OUT AGAIN WITH THE SAME BEHAVIOR AS START-UP. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121631 RD SET DCI OXIMETER DQA MASIMO - 40 PARKER 4050 E16JPS 00843997009805

    Patients

    Seq Age Sex Outcome Treatment
    1