BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-87

    MDR report key: 4593639 · Received February 18, 2015

    Report

    Report Number
    2031172-2015-00140
    Event Type
    Malfunction
    Date Received
    February 18, 2015
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K091241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING TESTING THE UNIT WAS NOT ABLE TO POWER ON. INTERNAL INSPECTION REVEALED THAT THE CONNECTION BETWEEN THE AC POWER MODULE AND SYSTEM BOARD (SOLDER JOINT) AT THE GROUND PIN WAS LOOSENED. THE BROKEN SOLDER JOINT WAS RE-SOLDERED AND THE UNIT FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR # WAS 2031172-2014-00327. HOWEVER, THE CORRECT MDR # SHOULD BE 2031172-2015-00140.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT TURNED OFF COMPLETELY BY ITSELF. CUSTOMER STATES THAT THE AC POWER LED DOES NOT ILLUMINATE WHEN AC POWER IS APPLIED. CUSTOMER IS UNAWARE OF WHETHER AN ALARM OR ALERT OR PAGE OCCURRED AT THE TIME THIS UNIT FAILED. NO PT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117253 RAD-87 OXIMETER DQA MASIMO CORPORATION 22745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female