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

Model Number	HT70PM-JP-NA
Medical Device Problem Codes	Defective Alarm (1014); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e initial reporter cannot be provided due to japanese privacy regulations.Japan medtronic personnel reported event to manufacturer on behalf of the customer.Issue identified during product analysis.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during servicing by medtronic service personnel, the pump of this ht70 ventilator was noted to have a leak, the positive end expiratory pressure (peep) was found to be unstable and the control board  shutdown buzzer was noted to have a failure.  while the service personnel (sp) was servicing this ht70 ventilator, the pump of the ventilator was noted to have a leak and the positive end expiratory pressure (peep) was lower than the set pressure and the shutdown alarm did not sound.The sp replaced the pump and manifold assembly, the on/off solenoid valve and the control board.The unit passed all calibrations and tests as per the manufacturer's specifications at the time of service.The cause of the reported event of the pump leak was isolated to a potential fault in the pump and manifold assembly.The cause of the peep issue was isolated to a potential fault in the on/off solenoid valve.These events are included in a trending and monitoring plan.The cause of the reported issue of the shutdown buzzer alarm not sounding was isolated to a potential fault on the control board (c159).This ventilator is in the scope of the current 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 during servicing by medtronic service personnel, the pump of this ht70 ventilator was noted to have a leak, the positive end expiratory pressure (peep) was found to be unstable and the control board  shutdown buzzer was noted to have a failure. 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: 22160981
• Report Number: 2023050-2025-00015
• Device Sequence Number: 7266165
• 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): 06/06/2025

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: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2014
• 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: 2024500-05-13-2025-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown