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	07/15/2024
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 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
It was reported that while in use on a patient, this ht70 ventilator had a system error, the liquid crystal display (lcd) became dark, and ventilation stopped.The patient was removed from the ventilator and was placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Correction to section d 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 d8 updated section h6 evaluation codes updated due to notification of 3rd party device repair method code - add additional code result code - remove c20 and add c13 conclusion code - remove d15 and add d02 component code - remove g07003 and add g07001 h3: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this ht70 ventilator had a system error, the liquid crystal display (lcd) became dark, and ventilation stopped.The device was not available for evaluation.Third-party service provider tokibo (tkb) performed the evaluation.Tkb confirmed the reported issue and replaced the pump.The unit was functional after part replacement.The cause of the event was isolated to a potential fault in the pump.The event is included in the 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.
Event or Problem Description
It was reported that while in use on a patient, this ht70 ventilator had a system error, the liquid crystal display (lcd) became dark, and ventilation stopped.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 part return.Section h6 evaluation codes was updated due to analysis of returned part.Method code (annex b) - remove b17 and add b01and b24.Conclusion code (annex d)- remove d02 and add d15.H3 device evaluation summary was updated due to analysis of returned part.Medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this ht70 ventilator had a system error, the liquid crystal display (lcd) became dark, and ventilation stopped.A review of the logs confirmed a loss of ventilation to the patient at the time of the reported event.Third-party service provider tokibo (tkb) inspected the ventilator, confirmed the reported issue, and replaced the pump and manifold assembly.The unit was functional after part replacement.One pump and manifold assembly was returned to medtronic for failure investigation.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.Although the pump and manifold assembly were replaced by tkb, the returned components were analyzed and tested satisfactorily.With the information available a potential cause of the system error and loss of ventilation was identified to be power interruption however, the cause of power interruption could not be determined.The event is included in the 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.

• 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: 19983957
• Report Number: 2023050-2024-00015
• Device Sequence Number: 20613748
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2024

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: 07/22/2024
• Supplement Date Received by Manufacturer: 08/14/2024; 09/05/2024; 10/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 08/14/2024; 09/06/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown