BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 21284865 · Received January 31, 2025

    Report

    Report Number
    8020893-2025-00018
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    August 23, 2020
    Report Date
    January 31, 2025
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521077133
    PMA / PMN Number
    K151252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E INITAL REPORTER FROM THE FACILITY COULD NOT BE OBTAINED DUE TO AGE OF REPORTED EVENT. H3: DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, WHILE IN USE ON A PATIENT, THE ACTUAL TIDAL VOLUME OF THIS 840 VENTILATOR WAS DIFFERENT FROM THE SET VALUE AND THE VENTILATOR DID NOT ALARM AND THE "EXHALATION LOOP" COULD NOT BE CLOSED. THE VENTILATOR WAS NOT MADE AVAILABLE TO MEDTRONIC FOR EVALUATION. THIS ISSUE WAS RESOLVED BY NON-MEDTRONIC SERVICE PERSONNEL. THE NON-MEDTRONIC SERVICE PERSONNEL FOUND THAT THE OXYGEN (O2) FLOW SENSOR WAS DAMAGED. THE PLAUSIBLE CAUSE OF THE "VENTILATOR DID NOT ALARM" AND "EXHALATION LOOP COULD NOT BE CLOSED" COULD BE THERE BEING NO VIOLATION OF USER SETTABLE ALARM LIMITS. THE CAUSE OF THE REPORTED EVENT OF "TIDAL VOLUME DIFFERENT FROM THE SET VALUE" WAS ISOLATED BY NON-MEDTROINC PERSONNEL TO BE A POTENTIAL FAULT WITH THE THE O2 FLOW SENSOR. THE EVENTS ARE INCLUDED IN A TRENDING AND MONITORING PLAN. 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

    IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, WHILE IN USE ON A PATIENT, THE ACTUAL TIDAL VOLUME OF THIS 840 VENTILATOR WAS DIFFERENT FROM THE SET VALUE AND THE VENTILATOR DID NOT ALARM AND THE "EXHALATION LOOP" COULD NOT BE CLOSED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165779 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 4-840220DIUA-EN 10884521077133

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male