MAUDE Adverse Event Report: COSTA MESA MFG DC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number HT70M-JP-NA

Device Problems Defective Alarm (1014); No Flow (2991)

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

Event Date 06/27/2023

Event Type  malfunction  

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: device evaluation summary: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the me dtronic service engineer.Medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this ht70 ventilator did not generate an alarm when the screen went blank and ventilation stopped the device was not available for evaluation.The unit was evaluated by a medtronic approved third party, tokibo (tkb).The unit would not start upon power on.Tkb service personnel replaced the main control board.The likely cause of the event was isolated in the field to a fault in main control board.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.

Event Description

It was reported that while in use on a patient, this ht70 ventilator did not generate an alarm when the screen went blank and ventilation stopped. the patient was placed on an alternate ventilator without injury.

Manufacturer Narrative

Section h6 evaluation code method - remove b17 and add b01 result add c02 conclusion - remove d02 and add d01 component code - remove g02005 and add g07001 h3 device evaluation summary: updated due to part return medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this ht70 ventilator did not generate an alarm when the screen went blank and ventilation stopped the unit was evaluated by a medtronic approved third party, tokibo (tkb).The unit would not start upon power on.Tkb suspected main control board to be faulty and replaced the main control board.The unit was informed to be in working condition.One control board was returned to medtronic for failure investigation.On further investigation, it was found that capacitor c92 had internally shorted.The analysis determined that the failure of capacitor c92 while the device is in use on a patient would lead to a loss of ventilation.The main control board returned has been checked for other failures and none were found.When the faulty main control board was tested, the backup alarm activated as expected.The analysis could not duplicate the allegation that the device did not generate an alarm.The cause of the reported issue of unit stopped ventilating was isolated to faulty capacitor c92 of the main control board.However, the allegation of unit did not generate an alarm could not be confirmed.There is an existing previous internal investigation regarding the c92 issue.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.

Manufacturer Narrative

Section h6 device code added.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): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17379952
• MDR Text Key: 320043548
• Report Number: 2023050-2023-00021
• 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: 09/29/2023

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: 06/28/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/27/2023; 09/28/2023
• Supplement Dates FDA Received: 08/04/2023; 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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