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

Model Number	HT70PM-JP-NA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, the ht70 ventilator generated a continuous alarm and the ventilation stopped.The oxygen (o2) saturation of the patient temporarily decreased to 89%.The patient was manually ventilated and transferred to an alternate ventilator without injury.The patient recovered from the o2 saturation drop within two minutes.
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 event to manufacturer on behalf of the customer.H3: preliminary finding it was confirmed that even after the external battery was replaced, the power lamp lit up but did not start and an error log could not be obtained.The unit is currently at japan service and repair awaiting customer acceptance for repair.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 d unique identifier (udi) # updated section h6 evaluation code img section h9 fda 806# 2024500-05-13-2025-001-r.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the ht70 ventilator generated a continuous alarm and the ventilation stopped.The device was available for evaluation.The service personnel (sp) inspected the unit and found that even after the external battery was replaced, the power lamp lit up but did not start, and an error log could not be generated.No repairs were carried out.The suspected cause for the event was isolated to the control board.The ventilator is in the scope of the field corrective action.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 were updated due to analysis of returned part result code (annex c) additional code added conclusion code (annex d) remove d15 and add d02 component code (annex g) remove g02005 and add g0201201 medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the ht70 v entilator generated a continuous alarm and the ventilation stopped.The device was available for evaluation.The service personnel (sp) inspected the unit and found that even after the external battery was replaced, the power lamp lit up but did not start.No repairs were carried out as this unit is in the scope of the existing field corrective action, however the control board was removed and returned for analysis.One control board was returned to medtronic for analysis.Thermal damage was observed around the component capacitor c92.If a failure of capacitor c92 occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The cause for the event was isolated to the faulty capacitor c92 on the control board.The ventilator is in the scope of the field corrective action.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: 21848672
• Report Number: 2023050-2025-00012
• Device Sequence Number: 18130984
• Product Code: CBK
• UDI-Device Identifier: 10884521544321
• UDI-Public: (01)10884521544321(11)160729
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: HT70PM-JP-NA
• Device Catalogue Number: HT70PM-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 02/27/2026
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 08/05/2025; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2016
• 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