BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8

    MDR report key: 6081086 · Received November 7, 2016

    Report

    Report Number
    2031172-2016-01225
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 17, 2016
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: (MFR REPORT NUMBER) FROM 2031172-2016-01378 TO 2031172-2016-01225.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED DEVICE WAS EVALUATED. DURING INSPECTION, THE UNIT WAS FOUND TO HAVE MISSING DISPLAY SEGMENTS. INTERNAL INSPECTION INDICATED THE MISSING DISPLAY SEGMENTS ARE DUE TO AN INTERMITTENT FAILURE ON THE UI BOARD., CORRECTED DATA: THE INVESTIGATION RESULTS SHOULD HAVE BEEN SENT AS PART OF FOLLOW UP 001.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY DOES NOT PROVIDE "ALL NECESSARY INFORMATION." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734085 RAD-8 OXIMETER DQA MASIMO - 40 PARKER 22042

    Patients

    Seq Age Sex Outcome Treatment
    1