BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 18427047 · Received January 2, 2024

    Report

    Report Number
    8020893-2024-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    January 31, 2023
    Report Date
    January 2, 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. THE DISTRIBUTOR, LISTED BELOW, REPORTED THE EVENT TO MANUFACTURER ON BEHALF OF THE CUSTOMER. XOVIC COMPANY LIMITED THAMMARAT TATONYANG. SERVICE SUPERVISOR (662)090-2591/4 EXT.229 448,450 PHAHOLYOTNIN RD., PHAYATHAI BANGKOK 10400 THAILAND 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 EXTENDED SELF TEST (EST). THE DEVICE WAS AVAILABLE FOR EVALUATION. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR, CONFIRMED THE REPORTED ISSUE, FOUND UNIT GENERATED "INSPIRATORY AUTO ZERO SOLENOID NOT OPERATIONAL)" CODE, AND REPLACED THE INSPIRATORY FLOW MODULE (IFM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS AT THE TIME OF SERVICE. THE DEVICE WAS AVAILABLE FOR EVALUATION. ONE IFM PCBA WAS RETURNED FOR FAILURE INVESTIGATION. THE PART WAS VISUALLY INSPECTED WITH NO OBSERVED ANOMALIES. 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 AUTOZERO SOLENOID (SO1). THERE IS AN EXISTING PREVIOUS INTERNAL INVESTIGATION REGARDING THIS ISSUE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE EXTENDED SELF TEST (EST). 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
    1203817 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980A1ENNISB 10884521201897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown