BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 9578618 · Received January 10, 2020

    Report

    Report Number
    2936999-2020-00045
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Report Date
    February 27, 2020
    Manufacturer
    MEDIANA CO. LTD.
    Product Code
    PGJ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE PRODUCT WAS RECEIVED. THE DEVICE FAILED TO MEET SPECIFICATION. THE REPORTED COMPLAINT FOUND TOP <(>&<)> BOTTOM CASE DAMAGED AND TILT STAND DAMAGED. BATTERY HAVE TO BE REPLACED. NO NEW FORMAL INVESTIGATION IS REQUIRED, THE EVENT WILL BE INCLUDED IN TRENDING AND MONITORING. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. 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. 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 UNIT'S ALARM SOUNDS POWERED ON BUT DOES NOT WORK PROPERLY. IT WAS STATED THAT ALARM NEVER WORKS. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41555 OXIMAX N-595 PULSE OXIMETER PGJ MEDIANA CO. LTD. N595-1

    Patients

    Seq Age Sex Outcome Treatment
    1