BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-87

    MDR report key: 6675827 · Received June 28, 2017

    Report

    Report Number
    2031172-2017-00681
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 3, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K091241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED BY THE CUSTOMER THAT THE DEVICE USED DURING THE REPORTED EVENT HAS BEEN RETURNED TO SERVICE; AND THEREFORE, COULD NOT BE RETURNED TO MASIMO FOR EVALUATION. CUSTOMER RESPONSE RECEIVED ON 06/14/2017 STATING "THE ISSUE WAS DETERMINED TO BE DUE TO USER ERROR." AN ADDITIONAL RESPONSE FROM CUSTOMER RECEIVED ON 06/22/2017 INDICATING DEVICE IS WORKING FINE AND WILL NOT BE RETURNED, "I SPOKE TO THE RESPIRATORY MANAGER, (B)(6), HERE AT (B)(6) AND SHE VERIFIED THAT THE UNIT HAS BEEN WORKING PROPERLY. NO FURTHER ACTION IS NEEDED."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "'PT WAS TO HAVE A NOCTURNAL PULSE OX STUDY TO QUALIFY FOR HOME OXYGEN AT NIGHT. PULSE OX WAS SET UP AND PLACED ON PATIENT ON ROOM AIR. IN THE MORNING WHEN TRYING TO UPLOAD THE DATA FROM THE PULSE OX, THERE WAS NO DATA RECORDED ON THE PULSE OX UNIT'." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED. THIS FILE WAS OPENED TO ADDRESS FACILITY REPORT # MW5069606 RECEIVED BY MASIMO CORPORATION ON 06/05/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453439 RAD-87 OXIMETER DQA MASIMO - 40 PARKER 22742

    Patients

    Seq Age Sex Outcome Treatment
    1