BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RD SET NEO

    MDR report key: 6460297 · Received April 5, 2017

    Report

    Report Number
    2031172-2017-00407
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    March 16, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K042536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE SENSOR USED DURING THE REPORTED EVENT WAS DISCARDED; AND THEREFORE, COULD NOT BE RETURNED TO MASIMO FOR EVALUATION. IF NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFANT WAS RESUSCITATED UPON DELIVERY, INTUBATED, VENTILATED, IV ACCESS WAS OBTAINED, VOLUME ADMINISTERED PER NRP PROTOCOLS AND WITH A GOOD HEART RATE. AT APPROXIMATELY 30 MINUTES INTO DELIVERY THE CLINICIANS WERE UNABLE TO OBTAIN A SPO2 READING ON THE RAD-87 AND RADICAL-7 TS WITH RD PATIENT CABLE. BOTH RD INFANT AND RD NEO WERE USED TO OBTAIN A READING. THE NEONATOLOGIST CARING FOR THE INFANT BECAME VERY DISGRUNTLED AND TOLD THE NURSES TO "GET THAT MONITOR OUT OF HERE AND GET SOMETHING THAT WORKS." THE INFANT WAS TRANSPORTED VIA HELICOPTER TO A HIGHER LEVEL OF CARE FACILITY. THERE WAS NO PRODUCT COLLECTED OR SAVED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242054 RD SET NEO OXIMETER DQA MASIMO - 40 PARKER 4003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RAD-87, RADICAL-7 TS