BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7

    MDR report key: 5449374 · Received February 19, 2016

    Report

    Report Number
    2031172-2016-00207
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 28, 2016
    Report Date
    January 28, 2016
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE UNIT WAS ABLE TO POWER ON, HOWEVER, DUE TO DEFECTIVE INTERFACE PINS THE DEVICE HAD POOR CONTACT, WHICH CAUSED THE INTERMITTENT ON AND OFF. THE INTERFACE PINS WERE REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER NINE (9) YEARS WITH NO PREVIOUS REPORTED ISSUES RELATED TO THIS REPORTED EVENT. CATALOG # WAS "20879" SHOULD BE "9031." PMA/510(K) WAS "K080238" SHOULD BE "K140188."

    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

    IT WAS REPORTED THAT THE RADICAL-7 GOES OFF INTERMITTENTLY & NEEDS BATTERY. THERE WERE NO CONSEQUENCES OR IMPACT TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104351 RADICAL-7 OXIMETER DQA MASIMO CORPORATION 20879 G02239

    Patients

    Seq Age Sex Outcome Treatment
    1