BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 8377679 · Received February 28, 2019

    Report

    Report Number
    2936999-2019-00148
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Report Date
    April 24, 2019
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    DQA
    UDI-DI
    10884521163454
    PMA / PMN Number
    K120773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE DEVICE WAS EVALUATED. THE PRODUCT IS USED IN DIAGNOSIS. THE REPORTED CONDITION WAS NOT CONFIRMED. PRODUCT MEETS MEDTRONIC SPEC IFICATION. COULD NOT DUPLICATE CUSTOMER COMPLAINT OF UNIT GIVING HIGH READINGS. THE UNIT WAS TESTED ALONG WITH A PORTABLE MONITOR ON THE SAME LIVE SUBJECT. BOTH DEVICES WERE TESTED AT THE SAME TIME. BOTH UNITS GAVE THE SAME READINGS. UNIT WAS ALSO TESTED USING A SRC-MAX AND UNIT GAVE ACCURATE READINGS. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY. THE REPORTED EVENT WAS NOT RELATED TO A REPORTED COMPLAINT EVENT. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE HAD HIGH PULSE RATE COMPARE TO ANOTHER MONITOR. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172876 NELLCOR OXIMETER DQA MEDIANA CO. LTD. 10005941 10884521163454

    Patients

    Seq Age Sex Outcome Treatment
    1