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	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ht70 ventilator generated a shutdown alarm, the unit screen went off and the ventilation stopped while the patient was connected. the patient was removed from the ventilator and was placed on an alternate ventilator without injury.
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 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 medtronic service engineer.It was reported that the ht70 ventilator generated a shutdown alarm, the unit screen went off and the ventilation stopped while the patient was connected.The device was not available to medtronic for evaluation.It was informed that the third party service provider tokibo (tkb) performed the evaluation repair and confirmed the reported issue since the unit did not start when the power was turned on.Tkb identified that there was a crack on the capacitor (c92) of the control board and replaced the ht70 control board and the unit passed all calibrations and tests as per manufacturer specifications.The cause of the event was isolated to a design issue of the capacitor c92 in the ht70 control board.There is an existing previous internal investigation regarding this issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Section d9 updated due to part return.Section h6 evaluation codes updated due to part return and evaluation.Method- remove b15 and b17 and add b13 and b01 section h3 device evaluation summary: updated due to part return and evaluation.Medtronic conducted an investigation based upon all information received.It was reported that the ht70 ventilator generated a shutdown alarm, the unit screen went off and the ventilation stopped while the patient was connected.It was informed that the third-party service provider tokibo (tkb) performed the evaluation/repair and confirmed the reported issue since the unit did not start when the power was turned on.Tkb identified that there was a crack on the c92 capacitor of the control board and replaced the ht70 control board.One control board was returned to medtronic for failure investigation.The control board was attached to test ventilator but the unit did not power cycle on.The control board was removed and upon inspection the c92 capacitor was found to be discolored and cracked.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 event was isolated to a damaged c92 capacitor on the control board.Analysis determined that the control board serial number was prior to the implementation of a change to address c92 failures.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: 18588575
• Report Number: 2023050-2024-00002
• Device Sequence Number: 7159840
• 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
• Report Date (Section B): 04/18/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2012
• 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