BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 18641082 · Received February 5, 2024

    Report

    Report Number
    8020893-2024-00061
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Report Date
    February 5, 2024
    Manufacturer
    NELLCOR PURITAN BENNETT IRELAND
    Product Code
    DQA
    UDI-DI
    10884521182547
    PMA / PMN Number
    K141518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OHAD YOSSEF HAY, MEIR COHEN, ITAMAR NITZAN, YAIR KASIRER, SARIT SHAHROOR-KARNI, YITZHAK YITZHAKY, SHLOMO ENGELBERG AND MEIR NITZAN. "PULSE OXIMETRY WITH TWO INFRARED WAVELENGTHS WITHOUT CALIBRATION IN EXTRACTED ARTERIAL BLOOD" SENSORS 2018, 18, 3457; DOI:10.3390/S18103457, 14 AUGUST 2018; ACCEPTED: 8 OCTOBER 2018; PUBLISHED: 15 OCTOBER 2018, HTTPS://WWW.MDPI.COM/JOURNAL/SENSORS THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER CRP NO. 1000199834/NC36. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, THE DEVICE HAD A DISCREPANCY IN SP02 MEASUREMENT, AN EXCEPTIONAL ERROR OF 17% WAS OBTAINED IN SP02 MEASUREMENT IN AN EXAMINATION WHERE SAO2 WAS 70%, THE ARTICLE DID NOT GO INTO FURTHER DETAIL ABOUT THE ERROR. THE CORRELATION COEFFICIENT BETWEEN THE DEVICE'S SPO2 AND SAO2 WAS 0.776, AND AFTER REMOVING THE MEASUREMENT WITH A 17% DISCREPANCY, THE CORRELATION COEFFICIENT INCREASED TO 0.857. THE CORRELATION COEFFICIENT BETWEEN SPO2 AND SAO2 WAS 0.845. THE POSITIVE VALUE OF THE MEAN DIFFERENCE BETWEEN SPO2 AND SAO2 IS IN ACCORDANCE WITH THE DISCREPANCY IN SPO2 MEASUREMENTS IN NEONATES FOUND IN ROSS ET AL. THE STANDARD DEVIATION OF THE TWO PULSE OXIMETERS WAS ABOVE 3%, SIMILAR TO THE STANDARD DEVIATION REPORTED FOR THE SPO2 DEVIATION FROM SAO2 IN NEONATES. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440318 NELLCOR OXIMETER DQA NELLCOR PURITAN BENNETT IRELAND NELLRESP-01 10884521182547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown