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

Model Number	HT70PM-WW-NA
Medical Device Problem Codes	Defective Alarm (1014); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e initial reporter: medtronic field service engineer reported on behalf of the customer h3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that this ht70 ventilator did not pass cal ibration.One ht70 ventilator was returned to medtronic for analysis.Ventilator logs were reviewed and several entries of expiratory flow sensor calibration failure were noted.The tubing/connections were checked and found that the tubing connecting the on/off solenoid valve to the pump and manifold assembly was disconnected.The tubing was then connected properly.Additionally, it was noted, the power-off/shut-down alarm sounded audibly weak and shortly thereafter, the alarm went silent and therefore, the control board was replaced.The unit passed all calibrations and tests per the manufacturer's specifications.The cause of the reported event was an issue with the tubing connecting the on/off solenoid valve to the pump and manifold assembly.This event is included in a data monitoring plan.The cause of the secondary issue of the shutdown alarm sounded audibly weak was isolated to fault on the control board.Further action was not required because the ventilator is within the scope of the capacitor c159 field corrective action which can result in failure of the shutdown alarm to annunciate.The ventilator is within the scope of a 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that this ht70 ventilator did not pass calibration.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: 22168529
• Report Number: 8020893-2025-00110
• Device Sequence Number: 9208875
• Product Code: CBK
• UDI-Device Identifier: 10884521544413
• UDI-Public: 10884521544413
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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-WW-NA
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• 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: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2019
• 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