BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASIMO PATIENT SAFETY NET

    MDR report key: 4081106 · Received August 29, 2014

    Report

    Report Number
    2031172-2014-00171
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    MSX
    PMA / PMN Number
    K071047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FACILITY NAME AND CONTACT INFORMATION WAS NOT AVAILABLE. THE UNIT WAS NOT RETURNED TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. NO PATIENT INCIDENT REPORTED. THIS IS A FOLLOW UP TO THE USER FACILITY REPORT SUBMITTED AND RECEIVED BY MASIMO. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "MASIMO (OXYGEN MONITORING) MAIN SCREEN AND PT SCREEN SHOWED NO READINGS. CORD REPLACED AND MOST LIKELY DEFECTIVE." NO PATIENT INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527730 MASIMO PATIENT SAFETY NET MSX MASIMO CORPORATION PSN

    Patients

    Seq Age Sex Outcome Treatment
    1