MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC. HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HT70M-JP-NA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information and section e initial reporter cannot be provided due to japanese privacy regulations.Section e: japan.Medtronic personnel reported the event to manufacturer on behalf of the customer.H3: medtronic received the suspect device/component from the customer, but the device has not yet been evaluated to date.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that while in use on a patient, the ventilation stopped on this ht70 ventilator and it could not be activated and the unit also generated and displayed a "system error" message.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section d9 updated section h6 evaluation codes updated due to device evaluation method code (annex b): remove b17 and add b01 and b24 result code (annex c): remove c20 and add c13 conclusion code (annex d): remove d15 and add d02 component code (annex g): remove g07003 and add g02005 h3 device evaluation summary: updated due to device evaluation medtronic conducted an investigation based upon all information received.T was reported that while in use on a patient, the ventilation stopped on this ht70 ventilator and it could not be activated and the unit also generated and displayed a "system error" message.The device was available for evaluation.The service personnel (sp) inspected the ventilator, could not duplicate the reported issue and based on the logs, sp replaced the ht70 control board and single board computer (sbc).Additionally, sp replaced pump and manifold assembly since the system leak value was outside the allowable range and the on/off solenoid valve due to positive end expiratory pressure (peep) was outside the permissible range.Sp replaced the case assembly, overlay assembly due to damage and performed two yearly preventive maintenance (pm).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the event was isolated to potential fault in ht70 control board and/or sbc.Additionally, investigation found pump and manifold assembly, on/off solenoid valve as faulty and case assembly, overlay assembly were damaged which are not related to the reported issue.The event is included in the trending and monitoring plan.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
Section d9 was updated due to part return section h6 evaluation codes updated due to returned part analysis result code (annex c): add c13 conclusion code (annex d): remove d02 and add d01 component code (annex g): remove g02005 and add g0201201 h3 device evaluation summary: updated due to device evaluation medtronic conducted an investigation based upon all information received.T was reported that while in use on a patient, the ventil ation stopped on this ht70 ventilator and it could not be activated and the unit also generated and displayed a "system error" message.The device was available for evaluation.The service personnel (sp) inspected the ventilator, could not duplicate the reported issue and based on the logs, sp replaced the ht70 control board and single board computer (sbc).Additionally, sp replaced pump and manifold assembly since the system leak value was outside the allowable range and the on/off solenoid valve due to positive end expiratory pressure (peep) was outside the permissible range.Sp replaced the case assembly, overlay assembly due to damage and performed two yearly preventive maintenance (pm).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The pump and manifold assembly, on/off solenoid valve, case assembly and overlay assembly were not returned to medtronic.One sbc board was returned to medtronic for further analysis.The component was visually inspected and functionally tested with no m alfunction or product deficiency observed.One ht70 control board was returned to medtronic for further analysis.Visual inspection observed that the c92 capacitor was damaged.Further testing revealed the c92 capacitor had shorted.If a failure of the c92 occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The cause of the reported issue was isolated to a faulty c92 capacitor on the ht70 control board.There is an existing previous internal investigation regarding this issue.Although the sbc board was replaced in the field, the returned component was tested satisfactorily.Additionally, investigation found pump and manifold assembly, on/off solenoid valve outside of specified ranges and case assembly, overlay assembly were damaged which are not related to the reported issue.These events are included in the trending and monitoring plan.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.

• Brand Name: HT70 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20447306
• Report Number: 2023050-2024-00019
• Device Sequence Number: 8524349
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: 10884521542075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HT70M-JP-NA
• Device Catalogue Number: HT70M-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 01/27/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/13/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown