BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 12068193 · Received June 25, 2021

    Report

    Report Number
    2936999-2021-00617
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    June 25, 2021
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    UDI-DI
    10884521163454
    PMA / PMN Number
    K120773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE SPEAKER IN THE MONITOR WAS DEFECTIVE. IT WAS REPORTED THAT THE PRODUCT GAVE AN ERROR MESSAGE OF ERROR CODE 910. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A COMPONENT FAILURE. IT WAS ALSO REPORTED THAT THE JOG DIAL ON THE PULSE OX MONITOR NEEDED TO BE REPLACED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING SERVICE AND REPAIR, THE DEVICE HAD NOISE AND WAS NOT WORKING PROPERLY, SOUNDS DID NOT COME CLEAR AND HAD AN ERROR 910 THAT WAS RELATED TO SPEAKER AND HAD JOG DIAL MALFUNCTION. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE HAD DEFECTIVE SPEAKER WHERE SOUNDS DID NOT COME CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965116 NELLCOR OXIMETER DQA MEDIANA CO. LTD. 10005941 10884521163454

    Patients

    Seq Age Sex Outcome Treatment
    1