BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO COP.

    MDR report key: 1171979 · Received September 22, 2008

    Report

    Report Number
    MW5008376
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    MASIMO CORP.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MASIMO RADICAL-7 RED PC12 CABLE CAUSED LOW O2 SATURATION READINGS BY 37% WHEN CABLE FLEXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASIMO COP. RED PC-12 INTERFACE CABLE FOR RADICAL 7 PULSE OXIMETER DQA MASIMO CORP. 2060 8D003

    Patients

    Seq Age Sex Outcome Treatment
    1