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

Model Number HT70PM-JP-NA

Device Problems Defective Alarm (1014); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Section e initial reporter: medtronic representative reported to manufacturer due to the initial reporter from the facility could not be provided due to (b)(6) privacy regulation.Medtronic received the suspect device/component from the customer, but the device has not yet been evaluated to date.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that while in use on a patient, this ht70 ventilator's alarm did not sound and air flow stopped.The patient was transferred to a back up ventilator without injury.

Manufacturer Narrative

H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that this ht70 ventilator's alarm did not sound and the air flow stopped.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not confirm the reported issue.The sp replaced control board, single board computer (sbc) due to a shutdown and the log downloading failure as an additional findings.The sp performed preventive maintenance (pm) and replaced coin battery, cable assembly, fan.The ventilator passed all tests and calibrations per manufacturer specifications at the time of service.The investigation determines a plausibility of reported issue due to the potential fault isolated with the sbc.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.

Manufacturer Narrative

Additional code added to section h6 device codes.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that this ht70 ventilator's alarm did not sound and the air flow stopped.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not confirm the alarm issue but there was lov (loss of ventilation/ air flow stopped).The sp replaced the control printed circuit board assembly (pbba) and single board computer (sbc) due to a shutdown and the log downloading failure as additional findings.Sp also replaced the coin battery, cable assembly, fan under preventive maintenance (pm).The ventilator passed all test and calibrations per manufacturer specifications at the time of service.One ht70 control pcba and one sbc were received for failure analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.With the information available the investigation determines a plausibility of the reported issue, likely due to the potential fault isolated with the control pcba and/or the sbc.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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
• Type of Device: 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: 14030191
• MDR Text Key: 290789021
• Report Number: 2023050-2022-00007
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521544321
• UDI-Public: 10884521544321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2023

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
• Device Operator: Health Professional
• Device Model Number: HT70PM-JP-NA
• Device Catalogue Number: HT70PM-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 06/25/2022; 01/15/2023
• Supplement Dates FDA Received: 07/07/2022; 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1