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

Model Number HT70M-JP-NA

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter from the facility could not be provided due to (b)(6) 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.It was reported that a third party service provider performed the repair.Failure confirmation, cause, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that while in use on a home care patient, the ht70 ventilator generated a system error and ventilation stopped.The patient was removed from the ventilator and placed on an alternate ventilator without harm.

Manufacturer Narrative

Additional information in section a.H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by a medtronic service engineer.Medtronic conducted an investigation based upon all information received.It was reported that while in use on a home care patient, the ht70 ventilator generated a system error and ventilation stopped.The device was not available for evaluation.It was reported that third party service provider tokibo (tkb) could not duplicate the reported event during servicing but did confirm a record of a system error in the ventilator logs.The ventilator was functioning as intended.The single board computer (sbc) board was replaced as a part of preventive maintenance.Failure confirmation, cause, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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.

Manufacturer Narrative

Additional codes added to section h6 evaluation code method and result h3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a home care patient, the ht70 ventilator generated a system error and ventilation stopped.The device was available for evaluation.It was reported that the third party service provider tokibo (tkb) confirmed the system error in the logs during servicing but could not duplicate.The ventilator was functioning as intended.It was also reported that single board computer (sbc) board printed circuit board assembly (pcba) was replaced preventatively.The preventively replaced sbc pcba was returned to medtronic for further analysis.The component was visually inspected and functionally tested with no abnormalities noted.The part functioned as intended and designed.The returned component sbc pcba was analyzed and was testing satisfactorily.The reported event of system error was confirmed in the logs, however the loss of ventilation event was not confirmed.With the information available a likely cause could not be determined.The logs were reviewed and showed that the ventilator logged a system error and also an exception on (b)(6) 2021 @1:07.Eight minutes later the ventilator was powered down and then powered up again.The history log only notes the exception but not what caused it so the ventilator could have gone into a loss of ventilation.There is an exception file that is generated for any exception that the service department can access.Without the exception file, it is unable to identify if there is a software or hardware failure.The service history review of the ventilator was performed and found the last service was for an unrelated corrective issue and was released passing all functional tests.There is no indication this complaint event is due to a manufacturing issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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: 11621011
• MDR Text Key: 244003681
• Report Number: 2023050-2021-00014
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• 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
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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
• Patient Sex: Male