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

Model Number	HT70M-JP-NA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, the ht70 ventilator generated a shutdown alarm with a low sound, followed by a system error displayed on the screen.Although the unit's screen remained operational, the ventilation stopped, and was not able to perform ventilation.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section a and section e: initial reporter information and patient identifier information cannot be provided due to the restriction by the japan privacy regulation.Section e: japan medtronic personnel reported event to the manufacturer on behalf of the customer.H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.It was reported that the device will be evaluation by the third party service provider tokibo (tkb) in japan.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.
Additional Manufacturer Narrative
Section d4 updated unique identifier (udi)# section h6 evaluation codes updated due to additional information received method code (annex b) remove b17 and add b15 and b24 result code (annex c) remove c20 and add c13 conclusion code (annex d) remove d15 and add d02 component code (annex g) remove g07003 and add g02005 it was reported that while in use on a patient, the ht70 ventilator generated a shutdown alarm with a low sound, followed by a system error displayed on the screen.Although the unit's screen remained operational, the ventilation stopped, and was not able to perform ventilation.A review of the ventilator logs showed a device alert which potentially resulted in a loss of ventilation.The ventilator was not made available to medtronic for evaluation.It was informed that third-party service provider tokibo (tkb) performed the evaluation.Tkb could not duplicate the issue of ventilation stopped.However, observed that the "shutdown alarm did not sound enough".Tkb suspected the reported ventilation stoppage and the shutdown alarm issue was believed to be due to the main control board.Additionally, single board computer (sbc) board was replaced as a precaution.The unit was disposed of without repairing it.Review of the video provided confirmed the shutdown alarm and system error.The ventilator powered up and an error message appeared on the screen.The system was not connected to alternating current (ac) power and device alarm was observed to be faint sound after shut down.The suspected cause of the ventilation stoppage and the low sounding shutdown alarm was identified as a potential fault in the main control board.The event is included in a trending and 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.

• 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: 21701167
• Report Number: 2023050-2025-00011
• Device Sequence Number: 7910082
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: (01)10884521542075(11)131017(21)N13HT701015210
• 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,Followup
• Report Date (Section B): 09/09/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2013
• 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