BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED LNC-10

    MDR report key: 4359481 · Received December 5, 2014

    Report

    Report Number
    2031172-2014-00512
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 7, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K053477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DIRECTOR OF WOMEN'S SVS STATED THAT THEY ARE NOT ABLE TO OBTAIN A SUSTAINABLE PULSE OX READING FOR THE FIRST 10 MINS OF LIFE FOR THE NEONATE. THEY ARE USING THE RAD-87 AND GE DASH 4000 DEVICES WITH MASIMO SET TECHNOLOGY WITH A NEO SENSOR. THEY HAVE BEEN HAVING THIS ISSUE SINCE THEY HAVE STARTED THE NRP RESUSCITATION GUIDELINES. THE CUSTOMER STATED THAT THEY HAVE HAD THEIR BIOMED DEPT CHECK THE DEVICES AND THEY ARE WORKING WITHIN SPECIFICATIONS AND THAT WHEN THEY USE THESE DEVICES LATER ON (AFTER THE FIRST 10 MINS OF LIFE) THEY WORK WITHOUT ANY DIFFICULTIES. ADD'L INFO RECEIVED INDICATED THAT THE REPORTED ISSUE OCCURRED DURING A RESUSCITATION. THE DEVICE WILL SHOW A READING FOR A SHORT TIME AND THEN THE READING WOULD NO LONGER SHOW. WITH THE ALARM MESSAGE OF "SENSOR OFF" ALONG WITH THE AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788789 RED LNC-10 OXIMETER DQA MASIMO CORPORATION 21502 A12G117

    Patients

    Seq Age Sex Outcome Treatment
    1