BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 20214480 · Received September 13, 2024

    Report

    Report Number
    8020893-2024-00320
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    November 9, 2023
    Report Date
    September 13, 2024
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521201897
    PMA / PMN Number
    K193056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E - DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER IN SECTION E XOVIC COMPANY LIMITED SANTIWUT TANGMANEE, SERVICE MANAGER (662)090-2591/4 EXT.(B)(6) ISSUE IDENTIFIED DURING PRODUCT ANALYSIS. H3 DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED ON ALL INFORMATION RECEIVED.IT WAS REPORTED THAT THIS PB980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST) WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" MESSAGE. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR, CONFIRMED THE REPORTED ISSUE AND REPLACED INSPIRATORY FLOW MODULE (IFM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE VENTILATOR PASSED ALL CALIBRATIONS AND TESTS PER MANUFACTURER SPECIFICATIONS AT THE TIME OF SERVICE. ONE IFM PCBA WAS RETURNED FOR FAILURE INVESTIGATION. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED IFM PCBA, NO ANOMALIES WERE OBSERVED. THE PART WAS ATTACHED TO THE TEST VENTILATOR, POWERED UP BUT FAILED TJE EST CIRCUIT PRESSURE TEST ¿INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL¿. ANALYSIS DETERMINED THE IFM PCBA WAS PRIOR TO THE IMPLEMENTATION OF A CHANGE TO ADDRESS AUTOZERO SOLENOID (SO1) FAILURES; THEREFORE, NO FURTHER TESTING WAS PERFORMED. INVESTIGATION DETERMINED IF SO1 WERE TO FAIL WHILE IN USE ON A PATIENT, THE VENTILATOR RESPONSE WOULD BE TO ENTER BACKUP VENTILATION (BUV). THE LIKELY CAUSE OF THE EVENT WAS DETERMINED TO BE CONSISTENT WITH A FAULTY SO1. 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 EXTENDED SELF TEST (EST) WITH AN "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL" MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263309 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980A1ENNISB 10884521201897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown