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

Model Number 980X3ENDIUU

Device Problem Defective Alarm (1014)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that the 980 ventilator did not generate any volume or alarm sound during testing.However, error codes for a failed extended self test were present.The device was available for evaluation.The field service engineer (fse) evaluated the ventilator and observed that the breath delivery unit (bdu) audio was working as intended, but confirmed the unit was failing the gui (graphical user interface) audio alarm test.Fse observed error codes and replaced the gui board; however, this did not resolve the issue.The fse identified the gui speaker as the potential issue and replaced the part.The ventilator passed all testing per manufacturing specifications at the time of service and was returned to the customer.The reported event was isolated in the field to a fault in the gui speaker.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 the 980 ventilator did not generate any volume or alarm sound during testing.However, error codes for a failed extended self test (est) were present. the ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

Section d9 was updated due to part return additional codes added to section h6 evaluation code result.Correction to initial report (due to part return) section h6 evaluation code component code - remove g02033 and add g0600101 h3 device evaluation summary: updated due to part return medtronic conducted an investigation based upon all information received.It was reported that the 980 ventilator did not generate any volume or alarm sound during testing.However, error codes for a failed extended self test were present.The device was available for evaluation.The field service engineer (fse) evaluated the ventilator and and found primary audio alarm test codes.The sp further checked and isolated the issue to a faulty graphical user interface (gui) speaker.To solve the issue sp replaced the gui speaker.The unit passed all tests and calibrations as per manufacturer specifications at the time of service.One gui speaker was returned to medtronic for further analysis.A visual inspection of the returned part revealed no external anomalies.The returned part was attached to test unit and powered up.Analysis found there was no gui audio alarm and failed the extended self test (est) safety audible alarm system (saas) test failed.Further analysis isolated fault to the internal workings of the speaker which are securely enclosed.Analysis found gui speaker faulty.The cause of the event was isolated to a fault in gui speaker.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
• 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: 14060420
• MDR Text Key: 289065613
• Report Number: 8020893-2022-00062
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521172524
• UDI-Public: 10884521172524
• 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
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

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: 980X3ENDIUU
• Device Catalogue Number: 980X3ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1