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

Model Number PB980-S

Device Problem Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

It was reported by the fda (food and drug administration) via medwatch report (b)(4) that, while in use on a patient, a 980 ventilator was flashing and displaying a disconnection alarm with no audible sound.Reportedly the patient's saturation of peripheral oxygen (spo2) was decreasing due to circuit disconnect.No further information was provided or could be obtained.

Manufacturer Narrative

Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.This complaint was not reported by a customer, but through the fda, via medwatch number (b)(4).There was no reporter, no facility and no serial number of the ventilator to identify the reporting source.The medtronic complaint handling system was thoroughly reviewed and there were no similar complaints around the date of event reported.The maude data base report was reviewed and provided no additional information.A serial number was not provided, therefore a review of the appropriate device history records could not be performed.The potential cause of the event could not be established as not enough information was available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.This complaint was not reported by a customer, but through the fda, via medwatch number 5105183.There was no reporter, no facility and no serial number of the ventilator to identify the reporting source.The medtronic complaint handling system was thoroughly reviewed and there were no similar complaints around the date of event reported.The maude data base report was reviewed and provided no additional information.A serial number was not provided, therefore a review of the appropriate device history records could not be performed.The potential cause of the event could not be established as not enough information was available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the fda (food and drug administration) via medwatch report 5105183 that, while in use on a patient, a 980 ventilator was flashing and displaying a disconnection alarm with no audible sound.Reportedly the patient's saturation of peripheral oxygen (spo2) was decreasing due to circuit disconnect.No further information was provided or could be obtained.

Manufacturer Narrative

Correction to section h6 evaluation code conclusion.H3 device evaluation summary: updated this complaint was not reported by a customer, but through the fda, via medwatch number 5105183.There was no reporter, no facility and no serial number of the ventilator to identify the reporting source.The medtronic complaint handling system was thoroughly reviewed and there were no similar complaints around the date of event reported.The maude data base report was reviewed and provided no additional information.It was reported that while in use on a patient pb980 ventilator was flashing and displaying a disconnection alarm with no audible sound.Failure confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.After good faith efforts there is no additional information provided nor was contact information provided.Further investigation into the reported event determined a plausibility of no audible alarm likely caused due to design issue.There is an internal investigation related to this issue.A serial number was not provided, therefore a review of the appropriate device history records could not be performed.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

Additional information: h2, h7, h9; 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: 13595717
• MDR Text Key: 286346734
• Report Number: 8020893-2022-00038
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• 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: PB980-S
• Device Catalogue Number: PB980-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 08/18/2022; 08/18/2022
• Supplement Dates FDA Received: 08/22/2022; 02/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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