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

Model Number HT70M-JP-NA

Device Problem Defective Alarm (1014)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/04/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter information cannot be provided due to the restriction by the japan privacy regulation.Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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 Description

It was reported that while in use on a patient at a home care setting, it was observed that this ht70 ventilator was not working as usual and there was something abnormal.The oxygen saturation decreased and the patient was placed on a resuscitation bag.When therespiratory circuit was removed from the patient, the device failed to generate the usual alarm.The patient was then transferred to an alternate ventilator.

Manufacturer Narrative

Additional information received as follows: it was informed that, the repair was performed by tokibo (tkb) a third party service provider and no further information was available.No product was returned.Specifications could not be determined.Failure confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.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 Description

It was reported that while in use on a patient at a home care setting, it was observed that this ht70 ventilator was not working as usual and there was something abnormal.The oxygen saturation decreased and the patient was placed on a resuscitation bag.When therespiratory circuit was removed from the patient, the device failed to generate the usual alarm.The patient was then transferred to an alternate ventilator.

Manufacturer Narrative

Section d9 was updated due to part return section h6 evaluation codes updated due to part return method remove b17 and add b01 and b13 result remove c20 and add c19 h3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient at a home care setting, it was observed that this ht70 ventilator was not working as usual and there was something abnormal.The device failed to generate the usual alarm.The device was not available for evaluation.Medtronic was informed that third-party service provider tokibo (tkb) performed the evaluation.Tkb found a system error occurred when the power was turned on reported on the unit was not working as usual, operation test was performed to solve this issue.The tkb had confirmed the issue that the device failed to generate the usual alarm and replaced main control printed circuit board assembly (pcba) to solve this issue.Additionally tkb replaced a damaged battery connector pcba.The main control pcba was returned to medtronic for further analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.The battery connector pcba was returned to medtronic for further analysis.Visual inspection of the pcba found the red wire of the connector had been pinched.The component was functionally tested with no malfunction or product deficiency observed.The replaced component did resolve the issue of no alarm in the field by tkb however, the returned main control pcba was analyzed and tested satisfactorily.With the information available a likely cause could not be determined.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.

• 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: 14837077
• MDR Text Key: 302845484
• Report Number: 2023050-2022-00014
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521542075
• UDI-Public: 10884521542075
• 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: 11/02/2023

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: HT70M-JP-NA
• Device Catalogue Number: HT70M-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 08/23/2022; 11/02/2023
• Supplement Dates FDA Received: 08/25/2022; 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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