BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-5V

    MDR report key: 6297090 · Received February 2, 2017

    Report

    Report Number
    2031172-2017-00127
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    January 9, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K033998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE UNIT WAS ABLE TO POWER ON; HOWEVER, THE BOTTOM ROW OF LED DIGITS DOES NOT ILLUMINATE. COMPONENT C70 IS BROKEN OFF AND MISSING FROM THE INSTRUMENT BOARD. C70 IS REQUIRED FOR LED PWM DRIVING OF THE LOWER LED DIGITS. WITH C70 MISSING, THE BOTTOM ROW OF LEDS WILL NOT FUNCTION.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2ND ROW OF DISPLAY IS NOT WORKING. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81569 RAD-5V OXIMETER DQA MASIMO - 40 PARKER 25199

    Patients

    Seq Age Sex Outcome Treatment
    1