BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    980 VENTILATOR

    MDR report key: 16358289 · Received February 10, 2023

    Report

    Report Number
    8020893-2023-00101
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    August 28, 2022
    Report Date
    February 20, 2023
    Manufacturer
    ND
    Product Code
    CBK
    UDI-DI
    10884521172531
    PMA / PMN Number
    K131252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER CANNOT BE PROVIDED DUE TO JAPANESE PRIVACY REGULATIONS. JAPAN MEDTRONIC PERSONNEL REPORTED EVENT TO MANUFACTURER ON BEHALF OF THE CUSTOMER. ISSUE IDENTIFIED DURING PRODUCT ANALYSIS. DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) EXPIRATORY AUTO-ZERO TEST. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR, CONFIRMED THE REPORTED ISSUE AND REPLACED THE EXHALATION VALVE ASSEMBLY (EVA). THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS PER MANUFACTURER SPECIFICATIONS AT THE TIME OF SERVICE. THE EVA WAS RETURNED FOR FAILURE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED EVA WAS CONDUCTED AND NO ANOMALIES WERE OBSERVED. THE PART WAS ATTACHED TO THE TEST VENTILATOR AND POWERED UP. DURING THE EXTENDED SELF TEST (EST), THE DEVICE FAILED THE CIRCUIT PRESSURE TEST WITH THE MESSAGE "EXHALATION AUTOZERO SOLENOID NOT OPERATIONAL". AFTER A THOROUGH INVESTIGATION, A FAULTY SO1 REFERENCE DESIGNATOR COMPONENT IN THE 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 EVENT WAS IDENTIFIED AS A FAULTY S01 IN THE EVA OF THE EXHALATION MODULE. THERE IS AN EXISTING PREVIOUS INTERNAL INVESTIGATION 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

    H3: DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) EXPIRATORY AUTO-ZERO TEST. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR, CONFIRMED THE REPORTED ISSUE AND REPLACED THE EXHALATION VALVE ASSEMBLY (EVA). THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS PER MANUFACTURER SPECIFICATIONS AT THE TIME OF SERVICE. THE EVA WAS RETURNED FOR FAILURE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED EVA WAS CONDUCTED AND NO ANOMALIES WERE OBSERVED. THE PART WAS ATTACHED TO THE TEST VENTILATOR AND POWERED UP. DURING THE SST, THE DEVICE FAILED THE CIRCUIT PRESSURE TEST WITH THE MESSAGE "EXHALATION AUTOZERO SOLENOID NOT OPERATIONAL". AFTER A THOROUGH INVESTIGATION, A FAULTY SO1 REFERENCE DESIGNATOR COMPONENT IN THE 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 EVENT WAS IDENTIFIED AS A FAULTY S01 IN THE EVA OF THE EXHALATION MODULE. THERE IS AN EXISTING PREVIOUS INTERNAL INVESTIGATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 980 VENTILATOR FAILED THE SHORT SELF TEST (SST) EXPIRATORY AUTO-ZERO TEST. 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
    1066659 980 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK ND 980X3JADIJJ 10884521172531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown