BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 19274604 · Received May 8, 2024

    Report

    Report Number
    8020893-2024-00149
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    November 6, 2023
    Report Date
    May 8, 2024
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521172524
    PMA / PMN Number
    K193056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ISSUE IDENTIFIED DURING PRODUCT ANALYSIS. H3: DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) FOR EXHALATION AUTO ZERO NOT OPERATIONAL AND THE BATTERY WAS BAD.  THE DEVICE WAS AVAILABLE FOR EVALUATION. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR, CONFIRMED THE REPORTED ISSUES AND REPLACED THE EXHALATION VALVE ASSEMBLY (EVA) AND BATTERY. THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS AT THE TIME OF SERVICE. ONE BATTERY WAS RETURNED FOR FAILURE INVESTIGATION. ON VISUAL INSPECTION, NO ANOMALIES WERE FOUND. WHEN INSTALLED IN THE TEST VENTIL ATOR, THE BATTERY WOULD NOT CHARGE AND WOULD NOT POWER THE VENTILATOR CONFIRMING THE REPORTED ¿BAD¿ BATTERY. THE BQ WIZARD RESULTS SHOWED A HARDWARE SHORT CIRCUIT OR HSC FAILURE. THE RED BATTERY FAULT INDICATOR WAS OBSERVED. ONE EVA WAS RETURNED FOR FAILURE INVESTIGATION. ON VISUAL INSPECTION, NO ANOMALIES WERE FOUND. THE EVA WAS ATTACHED TO THE TEST VENTILATOR AND POWERED UP BUT FAILED THE EXTENDED SELF TEST (EST) CIRCUIT PRESSURE TEST/AUTO ZERO SOLENOID (EXHALATION). AFTER A THOROUGH INVESTIGATION, A FAULTY AUTOZERO SOLENOID (SO1) ON THE EXHALATION SENSOR PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OF THE RETURNED EVA WAS IDENTIFIED. IF AN SO1 FAILURE WERE TO OCCUR WHILE IN USE ON A PATIENT THE VENTILATOR RESPONSE WOULD BE TO ENTER BACKUP VENTILATION (BUV). THE CAUSE OF THE REPORTED ¿BAD¿ BATTERY WAS IDENTIFIED TO BE AN HSC. THE BATTERY EVENT IS INCLUDED IN A TRENDING AND MONITORING PLAN. THE CAUSE OF THE REPORTED SST FAILURE WAS IDENTIFIED AS A FAULTY AUTOZERO SOLENOID (SO1) ON THE EXHALATION SENSOR (PCBA) OF THE EVA. THERE IS AN EXISTING PREVIOUS INTERNAL INVESTIGATION REGARDING THIS ISSUE. 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 THAT THIS 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) FOR EXHALATION AUTO ZERO NOT OPERATIONAL AND THE BATTERY WAS BAD. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357954 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980X3ENDIUU 10884521172524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown