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

Model Number	HT70PM-JP-NA
Medical Device Problem Codes	Defective Alarm (1014); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, this ht70 ventilator shutdown and ventilation stopped. there was no injury to the patient.
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.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.
Event or Problem Description
Additional information received as follows: it was reported that while in use on a patient, this ht70 ventilator did not alarm, shutdown and ventilation stopped.The patient was placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section b5 updated section h6 device code- additional code added due to additional information received section h6 evaluation codes - updated due to device evaluation method - remove b17 and add b01 result - remove c20 and add c13 conclusion - remove d15 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 while in use on a patient, this ht70 ventilator did not alarm, shutdown and ventilation stopped.On the review of available logs, there was no evidence of shutdown or alarm malfunction.The device was available for evaluation.Service personnel (sp) inspected the unit and replaced the control board for the reported issue.Additionally, sp found system leak value was out of tolerance, the positive end-expiratory pressure (peep) value was out of tolerance, and the inlet filter assembly was broken.Sp also replaced the pump and manifold assembly, on/off valve, and inlet filter for additional issues.Sp performed the preventive maintenance and passed all the required calibrations and tests as per manufacturer specifications at the time of service.The cause of the event was isolated to the potential 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.The event is included in a trending and monitoring plan.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.
Additional Manufacturer Narrative
Section d9 updated due to part return section h6 evaluation codes - updated due to device evaluation conclusion code - remove d02 and add d01 component code - remove g02005 and add g0201201 h3: device evaluation summary: updated due to part return and analysis medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this ht70 ventilator did not alarm, shutdown and ventilation stopped.The device was available for evaluation.Service personnel (sp) inspected the unit and replaced the control board for the reported issue.Additionally, sp performed preventive maintenance and found system leak value was out of tolerance, the positive end-expiratory pressure (peep) value was out of tolerance, and the inlet filter assembly was broken.Sp also replaced the pump and manifold assembly, on/off valve, and inlet filter for additional issues.Sp performed the preventive maintenance and passed all the required calibrations and tests as per manufacturer specifications at the time of service.The pump and manifold assembly, on/off valve, and inlet filter were not returned to medtronic.One control board was returned for further analysis.The control board was installed into the ht70 test device and the system would not power cycle on.The control board was removed and the component c92 capacitor was found to be damaged.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 and activation of the backup alarm.The cause of the reported shutdown was isolated to the damaged c92 capacitor on the control board.There is an existing previous internal investigation regarding this issue.There is no evidence the device failed to alarm.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: 19274868
• Report Number: 2023050-2024-00008
• Device Sequence Number: 7659770
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 08/31/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/01/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• 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