BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 17596798 · Received August 22, 2023

    Report

    Report Number
    8020893-2023-00454
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    November 8, 2022
    Report Date
    March 13, 2025
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521172531
    PMA / PMN Number
    K193056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E INITIAL REPORTER CANNOT BE PROVIDED DUE TO JAPANESE PRIVACY REGULATIONS. DISTRIBUTOR: INNOMEDICS MEDICAL INSTRUMENTS INC. SECTION E. JAPAN MEDTRONIC PERSONNEL REPORTED EVENT TO MANUFACTURER ON BEHALF OF THE CUSTOMER. ISSUE IDENTIFIED DURING PRODUCT ANALYSIS. H3: DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED ON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST PORTION OF THE SHORT SELF TEST (SST) WITH AN "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR, CONFIRMED THE REPORTED ISSUE IN THE VENTILATOR LOGS, AND REPLACED THE INSPIRATORY FLOW MODULE (IFM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). ADDITIONALLY, THE PNEUMATIC INTERFACE PCBA WAS REPLACED AS A PRECAUTIONARY MEASURE. THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS AT THE TIME OF SERVICE. ONE IFM PCBA WAS RETURNED FOR FAILURE INVESTIGATION. THE PART WAS VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. THE PART WAS ATTACHED TO THE TEST VENTILATOR AND POWERED UP BUT FAILED THE SST CIRCUIT PRESSURE TEST ¿INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL¿. AFTER A THOROUGH INVESTIGATION, A FAULTY AUTOZERO SOLENOID (SO1) IN THE IFM PCBA 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 EVENT WAS IDENTIFIED AS A FAULTY AUTOZERO SOLENOID (S01) IN THE IFM PCBA. THERE IS AN EXISTING PREVIOUS INTERNAL I NVESTIGATION REGARDING THIS ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION G2 510K NUMBER CORRECTION SECTION E4 CORRECTION H6 EVALUATION CODE METHOD CODE (ANNEX B) ADD ADDITIONAL CODE CONCLUSION CODE (ANNEX D) REMOVE D0302 AND ADD D02 CORRECTION H3: ISSUE IDENTIFIED DURING PRODUCT ANALYSIS. H3: DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED ON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT THIS 980 VENTILATOR FAILED THE CIRCUIT PRESSURE TEST PORTION OF THE SHORT SELF TEST (SST) WITH AN "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR, CONFIRMED THE REPORTED ISSUE FROM LOGS AND BASED ON CODE REPLACED INSPIRATORY FLOW MODULE PRINTED CIRCUIT BOARD ASSEMBLY (IFM PCBA). PNEUMATIC INTERFACE (PI) PCBA WAS REPLACED AS A PRECAUTIONARY MEASURE. THE VENTILATOR PASSED ALL CALIBRATIONS AND TESTS PER MANUFACTURER SPECIFICATIONS AT THE TIME OF SERVICE. PI PCBA WAS NOT RETURNED FOR ANALYSIS. ONE IFM PCBA WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED IFM PCBA AND NO ANOMALIES WERE OBSERVED. THE PART WAS ATTACHED TO THE TEST VENTILATOR AND POWERED UP BUT FAILED THE SHORT SELF TEST (SST) CIRCUIT PRESSURE TEST WITH THE MESSAGE ¿INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL¿. AFTER A THOROUGH INVESTIGATION, A FAULTY AUTOZERO SOLENOID (SO1) ON THE IFM PCBA WAS IDENTIFIED. INVESTIGATION DETERMINED IF SO1 WERE TO FAIL WHILE IN USE ON A PATIENT, THE VENTILATOR RESPONSE WOULD BE TO ENTER BACKUP VENTILATION (BUV). THE CAUSE OF THE EVENT WAS ISOLATED TO FAULTY AUTOZERO SOLENOID (SO1) ON THE IFM PCBA. THE EVENT IS INCLUDED IN A DATA MONITORING PLAN. A REVIEW OF THE CONTRACT MANUFACTURER/ ORIGINAL EQUIPMENT MANUFACTURER (CM/OEM) ASSESSMENT INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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 CIRCUIT PRESSURE TEST PORTION OF THE SHORT SELF TEST (SST) WITH AN "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. 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
    51419 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 980X3JADIJJ 10884521172531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown