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

Model Number	HT70PM-WW-NA
Medical Device Problem Codes	No Flow (2991); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this ht70 ventilator did not turn on. the ventilator was not in use on a patient at the time of the reported ev ent.
Additional Manufacturer Narrative
H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that this ht70 ventilator did not turn on.  the device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue and replaced the ht70 control board.Additionally, sp found the unit failed the positive end expiratory pressure (peep) test and replaced the on/off solenoid valve to solve the issue.The device passed all testing per manufacturer specifications at the time of servicing.One ht70 control pcba (printed circuit board assembly) was returned to medtronic for further analysis.A visual inspection was carried out on the returned component and found a shortened capacitor c92, that would lead to a loss of power or ventilation to the unit.The additional part has been returned and is under investigation.The cause of the event was isolated to a damaged capacitor in the ht70 control board.There is an existing previous internal investigation regarding this issue.The manufacturing records for each device were 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 codes added, due to additional part analysis) to section h6 evaluation code result and component codes h3: device evaluation summary: updated due to additional part analyzed.Medtronic conducted an investigation based upon all information received.It was reported that this ht70 ventilator did not turn on.  the device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue and replaced the ht70 control board.Additionally, sp found the unit failed the positive end expiratory pressure (peep) test and replaced the on/off solenoid valve to solve the issue.The device passed all testing per manufacturer specifications at the time of servicing.One ht70 control pcba (printed circuit board assembly) was returned to medtronic for further analysis.A visual inspection was carried out on the returned component and found a shortened capacitor c92, that would lead to a loss of power or ventilation to the unit.One solenoid valve was returned to medtronic for failure investigation.The returned solenoid valve was installed on a test ventilator and powered on.The unit began to auto-trigger after changing the peep setting, confirming the solenoid valve to be faulty.The cause of the event was isolated to a damaged capacitor in the ht70 control board.There is an existing previous internal investigation regarding this issue.The manufacturing records for each device were 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.

• 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: 16820779
• Report Number: 2023050-2023-00013
• Device Sequence Number: 6820719
• Product Code: CBK
• UDI-Device Identifier: 10884521544413
• UDI-Public: 10884521544413
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K111146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: HT70PM-WW-NA
• Device Catalogue Number: HT70PM-WW-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2015
• 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