BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTREAM

    MDR report key: 20350778 · Received October 2, 2024

    Report

    Report Number
    8044004-2024-00018
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 10, 2024
    Manufacturer
    ORIDION MEDICAL 1987 LTD
    Product Code
    CCK
    UDI-DI
    10884521551879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION RECEIVED SHOWS THAT THIS EVENT IS A DUPLICATE OF ANOTHER ISSUE REPORTED UNDER REGULATORY REPORT #2936999-2024-01592. 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.

    Additional Manufacturer Narrative · 0

    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, PRIOR TO USE, THE POWER CORD CAUGHT FIRE AND GOT BURNED AND MELTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915593 MICROSTREAM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK ORIDION MEDICAL 1987 LTD PM35PSP2 120350902801 10884521551879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown