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

Model Number 980X1JADIJJ

Device Problem Defective Alarm (1014)

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

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

Covidien/medtronic has not received the device/component from the customer for evaluation.

Event Description

It was reported that during use on patient this 980 ventilator illuminated green alarm banner on gui (graphical user interface) with no audio sound generated.It was also mentioned that the device touch panel sound and dial knob sound was not working.Although patient intervention details are unknown, there was no harm to the patient.Upon reviewing logs it was confirmed that no audio alarm was generated at the time of reported event.

Manufacturer Narrative

Additional information section d9 additional information: h9 fda z-0966-2022 correction to initial report due evaluation: section h6 evaluation code method, result, conclusion and component codes.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during use on patient this 980 venti lator illuminated green alarm banner on gui (graphical user interface) with no audio sound generated.It was also mentioned that the device touch panel sound and dial knob sound was not working.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not duplicate the reported issue.The sp updated software installation rev ap.Ventilator passed all test and calibrations per manufacturer specifications at the time of service.Further investigation into the reported event determined a plausibility of no audible alarm likely caused due to design issue.There is an existing previous internal investigation regarding this 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.

Event Description

It was reported that during use on patient this 980 ventilator illuminated green alarm banner on gui (graphical user interface) with no audio sound generated.It was also mentioned that the device touch panel sound and dial knob sound was not working.Although patient intervention details are unknown, there was no harm to the patient.Upon reviewing logs it was confirmed that no audio alarm was generated at the time of reported event.

Manufacturer Narrative

In a previous supplemental report, the capa number and reason for the remedial action failed to be included.This report is being submitted in order to provide that information as a correction in field h10.During a regular internal review of complaints, it was identified that some medwatch reports associated with an fca were submitted without a correction/removal number in field h9 of 3500a form.Medtronic have initiated capa pr 576617 to address this gap.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
• Type of Device: 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: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 12872280
• MDR Text Key: 283943309
• Report Number: 8020893-2021-00199
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: 10884521171558
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131252
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

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
• Device Operator: Health Professional
• Device Model Number: 980X1JADIJJ
• Device Catalogue Number: 980X1JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 11/11/2021; 11/11/2021
• Supplement Dates FDA Received: 03/30/2023; 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0966-2022
• Patient Sequence Number: 1