MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980U1ENASAA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while in use on a patient, when the nursing staff were looking at advanced ventilation settings on this ventilator they pushed on the negative inspiratory force (nif) maneuver tab.The ventilator display went blank and then switched to service mode without power cycling.The patient desaturated to as low as 25%.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that, while in use on a patient, when the nursing staff were looking at advanced ventilation settings on this ventilator they pushed on the negative inspiratory force (nif) maneuver tab.The ventilator display went blank and then switched to service mode without power cycling.The device was available for evaluation.Service personnel (sp) inspected the ventilator and could not duplicate the reported condition.Review of the ventilator memory logs confirmed that the unit experienced a loss of ventilation at the time of the reported event.The sp replaced the breath delivery unit (bdu) central processing unit (cpu).The ventilator passed all tests and calibrations per manufacturer specifications at the time of service.The likely cause of the event was isolated in the field to the bdu cpu.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.
Event or Problem Description
Updated: it was reported to tga (therapeutic goods administration) that while in use on a patient, when the nursing staff was looking at advanced ventilation settings on this 980 ventilator, they pushed on the negative inspiratory force (nif) maneuver tab.The ventilator display went blank and then switched to service mode without power cycling.The patient desaturated to as low as 25%.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.For the same event, medtronic was informed the ventilator did not enter backup ventilation and there was no audible alarm.
Additional Manufacturer Narrative
H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported to tga (therapeutic goods administration) that while in use on a patient, when the nursing staff was looking at advanced ventilation settings on this 980 ventilator, they pushed on the negative inspiratory force (nif) maneuver tab.The ventilator display went blank and then switched to service mode without power cycling.For the same event, medtronic was informed the ventilator did not enter backup ventilation and there was no audible alarm.The device was available for evaluation.The service personnel (sp) inspected the ventilator and with the help of subject matter experts reviewed the diagnostic logs.The logs showed evidence of a potential issue with the breath delivery (bd) central processing unit (cpu) printed circuit board assembly (pcba) which resulted in the unit entering service mode after multiple activations of the nif maneuver.Prior to entering service mode, the logs indicated the bd cpu restarted, an alarm was generated contrary to the report and ventilation was lost (loss of ventilation (lov)) as a result of the failure, so therefore there was no backup ventilation.The sp replaced the bd pcba to solve the issue and installed the latest software.The ventilator passed all tests and calibrations according to the manufacturer's specifications at the time of service.With the information available the investigation determines a plausibility of lov, likely due to the potential fault isolated in the field with the bd cpu.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: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15575842
• Report Number: 8020893-2022-00176
• Device Sequence Number: 2781448
• Product Code: CBK
• UDI-Device Identifier: 10884521201385
• UDI-Public: 10884521201385
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 980U1ENASAA
• Device Catalogue Number: 980U1ENASAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• 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