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	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, the ventilation stopped suddenly on this ht70 ventilator.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the ventilation stopped suddenly on this ht70 ventilator.The unit was repaired by third-party service provider tokibo (tkb).No service report or no further info is available.One single board computer (sbc) printed circuit board assembly (pcba) was received for failure analysis.Could not duplicate customer complaint that unit stopped ventilation.Inspection of the pcba found no anomalies.Logs were reviewed and no issues were observed.The investigation found the device to function normally as expected.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.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
Additional information received as follows: it was reported that a third-party service provider tokibo (tkb) could not confirm the reported issue and sbc was replaced for prevention.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.

• 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: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 12384754
• Report Number: 2023050-2021-00023
• Device Sequence Number: 19735372
• Product Code: CBK
• UDI-Device Identifier: 10884521543942
• UDI-Public: 10884521543942
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2022

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: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 01/31/2022
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 01/07/2022; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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: Female