BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8

    MDR report key: 4973758 · Received July 15, 2015

    Report

    Report Number
    2031172-2015-00936
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR# WAS 2031172-2015-00926. HOWEVER, THE CORRECT MDR# SHOULD BE 2031172-2015-00936.

    Additional Manufacturer Narrative · 1

    OCCUPATION: SERVICE PERSONNEL. OPERATOR OF DEVICE: PATIENT/LAY USER. REPORT SOURCE: DISTRIBUTOR. PMA 510)K): K092838. THE RETURNED DEVICE WAS EVALUATED, BOTH MANUAL AND PRESET SIMULATION TESTS PASSED. THE DEVICE IS FUNCTIONING AS DESIGNED. NO PRODUCT PERFORMANCE ISSUE IDENTIFIED, BASED ON THE INVESTIGATION ABOVE, THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RAD-8 IS NOT "READING CORRECTLY". THE CUSTOMER WAS UNABLE TO PROVIDE DETAILS REGARDING ALARMS, ERROR MESSAGES, WHICH PARAMETER WAS AFFECTED, OR ANY FURTHER DETAILS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458351 RAD-8 DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 MASIMO SENSOR