MAUDE Adverse Event Report: COVIDIEN 760 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	G-760110DIUU-JP
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information cannot be provided due to the restriction by the (b)(6) privacy regulation.(b)(4).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, the 760 ventilator generated an alarm, stopped working, failed to deliver breaths and the safety valve opened.The patient was removed from the ventilator and was placed on an alternate ventilator without injury.Additionally, when the power was turned on again the device displayed the message "power on self-test (post) failed".
Additional Manufacturer Narrative
Correction section h6 evaluation code method and result.Component code added.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that 760 ventilator generated an alarm, st opped working, failed to deliver breaths and the safety valve opened.Additionally, when the power was turned on again the device displayed the message "power on self-test (post) failed".The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue in memory but could not duplicate.A test run was performed, and it was confirmed that the event was not duplicated.The ventilator passed all testing per manufacturer specifications at the time of service.The cause of the observed condition could not be determined.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.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: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,ie
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway,ie
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 12268893
• Report Number: 8020893-2021-00111
• Device Sequence Number: 4377267
• Product Code: CBK
• UDI-Device Identifier: 10884521180918
• UDI-Public: 10884521180918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: G-760110DIUU-JP
• Device Catalogue Number: G-760110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown