BEUDAMED
    FDA Adverse Event Death Summary report: N

    HT70 VENTILATOR

    MDR report key: 21368834 · Received February 12, 2025

    Report

    Report Number
    2023050-2025-00005
    Event Type
    Death
    Date Received
    February 12, 2025
    Date of Event
    January 17, 2025
    Report Date
    July 9, 2025
    Manufacturer
    NEWPORT MEDICAL INSTRUMENT, INC.
    Product Code
    CBK
    UDI-DI
    10884521544321
    PMA / PMN Number
    K111146
    Removal / Correction Number
    Z-1915-2025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: IMAGES OF THE SINGLE BOARD COMPUTOR (SBC) BOARD AND THE MAIN CONTROL BOARD WERE RECEIVED FOR REVIEW. THERE WAS THERMAL DAMAGE OBSERVED WHICH INCLUDED THE C92 CAPACITOR ON THE MAIN CONTROL BOARD. THERE IS AN EXISTING PREVIOUS INTERNAL INVESTIGATION REGARDING THIS ISSUE. THE ACTUAL SBC AND MAIN CONTROL BOARDS WERE RECEIVED BY MEDTRONIC AND ARE UNDERGOING ANALYSIS. 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.

    Additional Manufacturer Narrative · 0

    SECTION G9 FDA 806 NOTIFICATION NUMBER: 2024500-05-13-2025-001-R UPDATE TO SECTION D4 UNIQUE IDENTIFIER (UDI)# SECTION D9 WAS UPDATED DUE TO PART RETURN SECTION H6 EVALUATION CODES WERE UPDATED DUE TO ANALYSIS OF RETURNED PARTS METHOD CODE (ANNEX B) ADDITIONAL CODES ADDED RESULT CODE (ANNEX C) ADD ADDITIONAL CODE CONCLUSION CODE (ANNEX D) REMOVE D01 AND ADD D02 H3 DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT WHILE IN USE ON A TERMINALLY ILL PATIENT, THE HT70 VENTILATOR GENERATED AN ALARM AND VENTILATION STOPPED. THE SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP FOUND A SYSTEM ERROR AND REPLACED THE SINGLE BOARD COMPUTER (SBC) AND CONTROL BOARD. ADDITIONALLY, SP FOUND THE SYSTEM LEAK VALUE WAS OUTSIDE THE ALLOWABLE RANGE, SO REPLACED THE PUMP AND MANIFOLD ASSEMBLY. SP ALSO FOUND THAT THE POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALUE WAS OUTSIDE THE PERMISSIBLE RANGE, SO REPLACED THE ON/OFF VALVE. THE VENTILATOR PASSED ALL CALIBRATIONS AND TESTS PER MANUFACTURER SPECIFICATIONS AT THE TIME OF SERVICE. THE PUMP AND MANIFOLD ASSEMBLY AND ON/OFF VALVE WERE NOT RETURNED TO MEDTRONIC. ONE CONTROL BOARD WAS RETURNED TO MEDTRONIC FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED CONTROL BOARD, IN ADDITION TO THE IMAGE PROVIDED, SHOWED SIGNS OF DAMAGE TO CAPACITOR C92 ON THE CONTROL BOARD. IF A FAILURE OF CAPACITOR C92 OCCURS WHILE IN USE ON A PATIENT, THE VENTILATOR RESPONSE WOULD BE A LOSS OF POWER/VENTILATION FOR THE UNIT. THE SBC WAS RETURNED TO MEDTRONIC FOR ANALYSIS. THE COMPONENT WAS VISUALLY INSPECTED IN ADDITION TO THE IMAGE PROVIDED AND FUNCTIONALLY TESTED WITH NO MALFUNCTION OR PRODUCT DEFICIENCY OBSERVED. THE CAUSE OF THE EVENT WAS ISOLATED TO A FAULTY C92 CAPACITOR ON THE HT70 CONTROL BOARD. THE VENTILATOR IS IN THE SCOPE OF THE FIELD CORRECTIVE ACTION. ADDITIONAL SYSTEM LEAK AND PEEP ISSUE WAS ISOLATED TO POTENTIAL FAULT IN PUMP AND MANIFOLD ASSEMBLY AND ON/OFF VALVE. THE ADDITIONAL EVENTS ARE INCLUDED IN A DATA MONITORING PLAN. A MEDICAL SAFETY REVIEW (MSR) WAS PERFORMED AND DETERMINED THAT THE DEVICE COULD CONTRIBUTE TO THE REPORTED EVENT, AND THE RESULTS SHOW THAT REPORTED HARMS AND SEVERITIES ARE PROPERLY ASSESSED AND THE RESULTS ARE WITHIN THE RISK DOCUMENT AND THE CAUSAL RELATIONSHIP TO THE DEVICE. 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 WHILE IN USE ON AN ELDERLY, TERMINALLY ILL PATIENT, THE HT70 VENTILATOR GENERATED AN ALARM AND VENTILATION STOPPED. WHILE BEING TRANSFERRED TO AN ALTERNATE VENTILATOR, THE PATIENT EXPERIENCED CARDIAC ARREST AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, BUT THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904676 HT70 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK NEWPORT MEDICAL INSTRUMENT, INC. HT70PM-JP-NA 10884521544321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death