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	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information and section e initial reporter cannot be provided due to japanese privacy regulations.Section e: japan medtronic personnel reported the event to 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 service engineer.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 while in use on a patient, the ventilation suddenly stopped on this ht70 ventilator and the unit shut down.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Update to section d8: third party service additional information received.The third party service provider (b)(6) will be evaluating the unit if necessary.No product was returned.Failure confirmation, cause, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.After good faith efforts the information about the failure and contributing cause could not be determined.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Section h6 evaluation codes updated due to additional information and video received method code (annex b)- add additional codes result code (annex c)- remove c20 and add c13 and c02 conclusion code (annex d) - remove d15 and add d01 componenet code (annex g) remove g07003 and add g0201201 h3 additional information: it was reported that while in use on a patient, the ventilation suddenly stopped on this ht70 ventilator and the unit shut down.Third party repair personnel, tokibo (tkb), along with the video returned for evaluation found unit does not start when powered on, and replaced the main control board due to damage to the capacitor (c92).If a failure of the c92 capacitor occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The cause of the power on issue was isolated in the field due to a faulty c92 on the control board.There is an existing previous internal investigation regarding this issue.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: 18980578
• Report Number: 2023050-2024-00004
• Device Sequence Number: 20490482
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: 10884521542075
• 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,Followup
• Report Date (Section B): 10/21/2024

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: 02/28/2024
• Supplement Date Received by Manufacturer: 02/28/2024; 10/17/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/16/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2011
• 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