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

Model Number	HT70PM-JP-NA
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h9 fda 806 notification number: 2024500-05-13-2025-001-r section e initial reporter cannot be provided due to japanese privacy regulations.Japan medtronic personnel reported event to manufacturer on behalf of the customer.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that the ht70 ventilator generated a background check alert "assert error" message and the unit's alarm sounded for a moment, then the device silenced on its own when the power was switched off.The service personnel (sp) inspected the ventilator, replaced the ht70 control board since the shutdown buzzer alarm test failure was observed.Additionally, sp replaced the light emitting diode (led) display and direct current (dc) inverter due to damage and performed yearly preventive maintenance (pm).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One ht70 control board was returned to medtronic for analysis.The returned ht70 control board was attached to failure investigation test ventilator for analysis and the alarm did not self activate.Later, the unit was power cycled off, the alarm beep was observed to be short due to capacitor c159 and confirming the control board to be faulty.Failure of c159 could result in the shutdown alarm failing to annunciate.The cause of the event was determined to be faulty capacitor c159 on the control board.The ventilator is in the scope of a 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.
Event or Problem Description
It was reported that the ht70 ventilator generated a background check alert "assert error" message and the unit's alarm sounded for a moment, then the device silenced on its own when the power was switched off.The ventilator was not in use on a patient at the time of the reported event.

• 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: 22337659
• Report Number: 2023050-2025-00030
• Device Sequence Number: 8962933
• Product Code: CBK
• UDI-Device Identifier: 10884521544321
• UDI-Public: 10884521544321
• 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
• Report Date (Section B): 06/26/2025

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: HT70PM-JP-NA
• Device Catalogue Number: HT70PM-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2014
• 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
• 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