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

Model Number 980X1ENDIUU

Device Problem Defective Alarm (1014)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that, while in use on a patient, this 980 ventilator did not generate an audible alarm during a circuit disconnect.The device was available for evaluation.The medtronic field service engineer (fse) evaluated the device and found diagnostic codes.The fse replaced the user interface printed circuit board assembly (pcba).The ventilator passed all testing per manufacturer specifications at the time of service and was returned to the customer.The likely cause of the event was isolated in the field to a potential fault in the user interface pcba.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.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 980 ventilator did not generate an audible alarm during a circuit disconnect.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.

Manufacturer Narrative

Correction to section h6 evaluation code result, conclusion and component codes.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 980 ventilator did not generate an audible alarm during a circuit disconnect.The device was available for evaluation.The medtronic field service engineer (fse) evaluated the device and found diagnostic codes.The fse replaced the user interface printed circuit board assembly (pcba).The ventilator passed all testing per manufacturer specifications at the time of service and was returned to the customer.The user interface ii board was returned to medtronic for further analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.Analysis determined no fault found as the user interface ii board generated an audible alarm when the patient circuit was disconnected.Further investigation into the reported event determined a plausibility of no audible alarm likely caused due to design issue.There is an existing internal investigation related to 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.

Manufacturer Narrative

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.As part of correction activities, this supplemental medwatch is being submitted to correct this issue and provide the appropriate correction/removal number in field h9.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: 13044426
• MDR Text Key: 282526846
• Report Number: 8020893-2021-00214
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: 10884521171541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

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: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 08/22/2022; 08/22/2022
• Supplement Dates FDA Received: 08/23/2022; 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 8020893-03142022-01-C
• Patient Sequence Number: 1
• Patient Sex: Male