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

Model Number	HT70PM-JP-NA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
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 event to manufacturer on behalf of the customer.H3: medtronic received the suspect device/component from the customer, but the device has not yet been evaluated.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.
Event or Problem Description
It was reported that the ht70 ventilator generated a continuous beeping sound, the display on the monitor disappeared 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 d9 was updated due to device evaluation h6 evaluation codes updated due to device evaluation: method remove b21 and add b01 result remove c21 and add c13 conclusion remove d16 and add d02 component remove g07003 and add g02005.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that the ht70 ventilator generated a continuous beeping sound, the display on the monitor disappeared and the ventilation stopped while the patient was connected.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue of the unit stopped ventilating and replaced the control board.Sp also replaced the light-emitting diode (led) display and direct current (dc) inverter due to the flickering of the screen.Additionally, while evaluating the unit, sp replaced the inlet filter assembly due to breakage; right membrane and overlay assembly due to a disconnection.Sp also performed preventive maintenance.The unit passed all tests and calibrations as per manufacturer specifications at the time of service.The likely cause of the reported issue of the unit stopped ventilating was isolated to a fault in the control board.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
Section d9 was updated due to part return h6 evaluation codes updated due to part return and evaluation result - add additional code conclusion remove d02 and add d01 component remove g02005 and add g0201201 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 continuous beeping sound, the display on the monitor disappeared and the ventilation stopped while the patient was connected.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue of the unit stopped ventilating and replaced the control board.Sp also replaced the light-emitting diode (led) display and direct current (dc) inverter due to the flickering of the screen.Additionally, while evaluating the unit, sp replaced the inlet filter assembly due to breakage; right membrane and overlay assembly due to a disconnection.Sp also performed preventive maintenance.The unit passed all tests and calibrations as per manufacturer specifications at the time of service.The led display, dc inverter, inlet filter assembly, right membrane and overlay assembly were not returned to medtronic for further analysis.One control board was returned to medtronic for further analysis.The control board was installed into the test ventilator and the system would not power cycle on.Visual inspection confirmed c92 capacitor was found to be 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 in 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; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17898016
• Report Number: 2023050-2023-00029
• Device Sequence Number: 3366649
• Product Code: CBK
• UDI-Device Identifier: 10884521544321
• UDI-Public: 10884521544321
• 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): Unknown
• 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): 04/17/2024

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: HT70PM-JP-NA
• Device Catalogue Number: HT70PM-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/29/2023; 04/16/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 10/30/2023; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2017
• 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