BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 19219122 · Received May 1, 2024

    Report

    Report Number
    2936999-2024-00700
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    March 2, 2024
    Report Date
    June 12, 2024
    Manufacturer
    NELLCOR PURITAN BENNETT MEXICO SA
    Product Code
    DQA
    UDI-DI
    20884522041277
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H); MAX-I-I, MAX-I-I MAX INF O2 SENSOR I20 3-20 KG (LOT#:223110045H). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED SHOWS THAT THIS EVENT IS A DUPLICATE OF ANOTHER ISSUE REPORTED UNDER REGULATORY REPORT#: (B)(4). THIS FILE WILL BE CLOSED AND ALL FURTHER UPDATES PROCESSED UNDER THE ABOVE-REFERENCED REPORT FOR THIS EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT GAVE LOW SPO2 READINGS, ERRATIC SPO2 READINGS, AND NO SPO2 READINGS. THE SENSOR SITE WAS CHECKED/CHANGED EVERY 4-6 HOURS, WRAP WAS USED TO HOLD THE SENSOR IN PLACE, AND LED LIGHTING WAS USED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138147 NELLCOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA MAX-I-I 223110045H 20884522041277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11