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	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, the ht70 ventilator generated an abnormal alarm then unit shut down and the ventilation stopped. there was no patient injury.
Additional Manufacturer Narrative
Section a and section e: initial reporter information and patient identifier information cannot be provided due to the restriction by the japan privacy regulation.Section e: japan medtronic personnel reported event to the manufacturer on behalf of the customer.H3: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the ht70 ventilator generated an alarm then the unit shut down and the ventilation stopped.There was no patient injury.Log review shows evidence of loss of ventilation.The unit was not made available to medtronic for evaluation.Third-party service provider tokibo (tkb) evaluated the unit, observed that the unit generated a system error when the power was turned on.The unit shut down when the power pack battery was removed.So, tkb replaced the control board.The unit was informed to be functional after part replacement.On review of the video provided, a system error alarm was observed in the video on the display of the ventilator, indicating that there was an abrupt shutdown or issue with the ventilator.The cause of the reported event was isolated to a potential fault of the c92 capacitor on the control board.The ventilator is in the scope of the field corrective action (fca).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
Update section d4.Unique identifier (udi) # section d9 updated due to part return.Section h6 evaluation codes were updated due to analysis of returned part method code (annex b) additional code added result code (annex c) additional code added.H3 device evaluation summary: updated due to analysis of returned part medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the ht70 v entilator generated an alarm then the unit shut down and the ventilation stopped.Log review shows evidence of loss of ventilation.Third-party service provider tokibo (tkb) evaluated the unit, observed that the unit generated a system error when the power was turned on.The unit shut down when the power pack battery was removed.So, tkb replaced the control board.The unit was informed to be functional after part replacement.On review of the video provided, a system error alarm was observed in the video on the display of the ventilator, indicating that there was an abrupt shutdown or issue with the ventilator.One control board was returned to medtronic for analysis.Initial inspection of the unit found shorting of the c92 capacitor.If a failure of the c92 on the control board occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The cause of the reported event was isolated to a faulty c92 on the control board.The ventilator is in the scope of the field corrective action (fca).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 55112-4391 ; 8006464633
• MDR Report Key: 22155118
• Report Number: 2023050-2025-00014
• Device Sequence Number: 7274109
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: (01)10884521542075(11)110501
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1915-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown