BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO

    MDR report key: 1153486 · Received September 8, 2008

    Report

    Report Number
    MW5008240
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 8, 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

    ON THE EVENT DATE, THERE WAS AN OCCURRENCE INVOLVING A MASIMO RADICAL7 PULSE OXIMETER ON THE 4TH FLOOR WITH A REPORTED PROBLEM OF " NOT WORKING." IT WAS DISCOVERED THAT THE REUSABLE INTERFACE RED PC-12 CABLE WAS CAUSING LOW O2 SATURATION READINGS -APPROXIMATELY 30% LOW- WHEN TESTED WITH A SIMULATOR AND ON A PATIENT. MASIMO WAS IMMEDIATELY CONTACTED FOR INVESTIGATION. RISK MANAGEMENT AND ALL DEPARTMENT MANAGERS THAT USE MASIMO RADICAL7 PULSE OXIMETERS WERE IMMEDIATELY NOTIFIED. MASIMO WAS IN ON 8/8 TO CONFIRM OUR FINDINGS. THE PULSE OXIMETER, CABLE AND FINGER PROBE INVOLVED, AS WELL AS 2 ADDITIONAL CABLES FROM THE SAME LOT, WERE SENT TO MASIMO FOR INVESTIGATION. TWO SIMULATORS WERE SENT IN FOR SPOT-CHECKING IN THE NICU IF NEEDED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: USED TO DIAGNOSE OXYGEN SATURATION LEVEL WITH RADICAL7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASIMO LNOP PATIENT CABLE RED PC-12 DQA MASIMO CORP RED PC-12 CABLE 8D003

    Patients

    Seq Age Sex Outcome Treatment
    1