MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND PURITAN BENNETT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980X3JADIJJ
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
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 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 or Problem Description
It was reported that during use on a patient this 980 ventilator generated an inoperative (vent inop) alarm.The patient was removed from the ventilator and placed on an alternate ventilator with no injury reported.A review of the logs indicate a loss of ventilation at the time of reported event.
Additional Manufacturer Narrative
Section d9 was updated due device evaluation section h6 evaluation code 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 during use on a patient this 980 ven tilator generated an inoperative (vent inop) alarm.The device was available for evaluation.A review of the logs indicates a loss of ventilation at the time of reported event.The service personnel (sp) inspected the ventilator, confirmed the reported issue with code "inspiratory pressure sensor reading out of range" in memory, and replaced the inspiratory flow module (ifm) printed circuit board assembly (pcba).The ventilator passed all calibrations and tests per the manufacturer's specifications at the time of service.The cause of the event was isolated in the field to a potential fault in the ifm pcba.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 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.
Additional Manufacturer Narrative
Section d9 was updated due part return section h6 evaluation codes conclusion - remove d02 and add d15 component - remove g02005 and add g07001 h3: device evaluation summary: updated due to returned part analysis medtronic conducted an investigation based upon all information received.It was reported that during use on a patient this 980 ven tilator generated an inoperative (vent inop) alarm.A review of the logs indicates a loss of ventilation at the time of reported event.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue with code "inspiratory pressure sensor reading out of range" in memory, and replaced the inspiratory flow module (ifm) printed circuit board assembly (pcba).The ventilator passed all calibrations and tests per the manufacturer's specifications at the time of service.One ifm pcba was returned to medtronic for further analysis.The component was visually inspected and functionally tested with no ma function or product deficiency observed.The replaced component did resolve the issue in the field however, the returned component ifm 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.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PURITAN BENNETT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18401494
• Report Number: 8020893-2023-00686
• Device Sequence Number: 14458066
• Product Code: CBK
• UDI-Device Identifier: 10884521172531
• UDI-Public: 10884521172531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2024

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: 980X3JADIJJ
• Device Catalogue Number: 980X3JADIJJ
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 02/02/2024; 05/29/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/06/2024; 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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