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

Model Number	HT70M-JP-NA
Medical Device Problem Codes	No Flow (2991); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
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.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during servicing, the ht70 ventilator was observed to suddenly shut down from standby mode.The third party service personnel tkb (tokibo) evaluated the ventilator, replaced the control board and the unit was reported to be working after part replacement.One control board was returned to medtronic for analysis.The control board was attached to the failure investigation test ventilator for analysis.The ventilator would not power on.The power inductor (l2) on control board started to overheat, confirming the control board was faulty.Investigation determines if l2 were to fail while in use on a patient, the ventilator response would be a loss of ventilation (lov) to the patient.With the information available, the cause of the event was isolated to faulty l2 on the control board.The event is included in a data monitoring plan.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, the ht70 ventilator was observed to suddenly shut down from standby mode.The ventilator was not in use on a patient at the time of the reported event.Reportability reassessed based on the product analysis findings.

• 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: mike bocchino ; 15 hampshire street; mansfield, MA 02048 ; 8006464633
• MDR Report Key: 22461358
• Report Number: 2023050-2025-00031
• Device Sequence Number: 20977215
• Product Code: CBK
• UDI-Device Identifier: 10884521544321
• UDI-Public: (01)10884521544321(11)2017-04-21
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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: HT70M-JP-NA
• Device Catalogue Number: HT70M-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown