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

Model Number	980X1DEDRAC
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer (se) evaluated the device and confirmed the reported issue.The software was updated to the most current version.The ventilator passed all tests and calibrations at time of service.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, while in use on a patient, this 980 ventilator ¿jumped into emergency ventilation with the message extended self test (est) required".The patient was removed from the ventilator and placed on an alternate ventilator with no harm or injury.
Additional Manufacturer Narrative
Correction to section d model # component code added.Additional device evaluation summary: it was reported that the pb980 ventilator jumped into emergency ventilation with the message "extended self test (est) required".One pb980 ventilator was evaluated.The service personnel (sp) inspected the ventilator, found the unit indicated to perform est and confirmed the reported issue of "backup ventilation (buv)" from memory.To solve the issue, sp updated the unit with the latest software version as per r7.2 instructions.The device passed all required functional tests and calibrations.It was returned to the customer in working condition.The investigation could not determine a cause of the event.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.
Event or Problem Description
It was reported that, while in use on a patient, this 980 ventilator ¿jumped into emergency ventilation with the message extended self test (est) required".The patient was removed from the ventilator and placed on an alternate ventilator with no harm or injury.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11454305
• Report Number: 8020893-2021-00041
• Device Sequence Number: 3360180
• Product Code: CBK
• UDI-Device Identifier: 10884521171596
• UDI-Public: 10884521171596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 980X1DEDRAC
• Device Catalogue Number: 980X1DEDRAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1