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 Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that while performing the extended self test (est) and short self test (sst), this 980 ventilator's alarm flashes on the display but does not have any alarm sound. the ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.Medtronic conducted an investigation based on all information received.It was reported that while performing the extended self test (est) and short self test (sst), this 980 ventilator's alarm flashes on the display but does not have any alarm sound.  the device was not available for evaluation.The customer called to report issue only, as the device is out of warranty medtronic was not authorized to perform evaluation at this time.Since the device software was updated on march 22, 2023 to rev.Ae, it is highly unlikely that the event is related to the fca 806# 8020893-03142022-01-c: fda # z-0966-2022.The cause of the reported event could not be established.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17379992
• MDR Text Key: 319759978
• Report Number: 8020893-2023-00426
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/24/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2018
• 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