BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAR

    MDR report key: 23203425 · Received October 2, 2025

    Report

    Report Number
    9680661-2025-00023
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 2, 2025
    Report Date
    December 14, 2025
    Manufacturer
    COVIDIEN
    Product Code
    CAH
    PMA / PMN Number
    K941676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A5A, A5B, D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED BREAKAGE IN THE TUBE. FUNCTIONALLY, PERFORMED THE LEAKAGE TEST ON THE DEVICE RETURNED AND THE RESULT WAS FAILED. IT WAS REPORTED THAT THE CIRCUIT DID NOT PASS LEAK TEST WITH THE MECHANICAL FAN. THE FAN WAS CHANGED BUT CONTINUED TO INDICATE FAILURE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 300/1378, 3300/13783 ADT ANAESTHESIA CIRCUIT PVC, LOT# 24M0434FAX. PB980, PB980-S 980 VENTILATOR UNKNOWN, LOT# P1366. 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

    PLI10 AND 20: IT WAS REPORTED THAT THE CIRCUIT DID NOT PASS LEAK TEST WITH THE MECHANICAL FAN. THE FAN WAS CHANGED BUT CONTINUED TO INDICATE FAILURE. THE ENTIRE CIRCUIT WAS CHANGED. THERE WAS NO PATIENT INVOLVED. PLI30: IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE LEAK TEST PORTION OF THE SHORT SELF TEST (SST). THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425988 DAR FILTER, BACTERIAL, BREATHING-CIRCUIT CAH COVIDIEN 351/5410 25C0104FAX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE NOTES ON H11.