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

Model Number	760
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for further evaluation.Upon receipt, an investigation will be performed, and the results will be submitted within a supplemental mdr.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use on a patient, the safety valve opened and ventilation stopped.The patient was transferred to an alternate ventilator with no patient harm.
Additional Manufacturer Narrative
Correction to section h6 evaluation codes method, result and conclusion.Device evaluation summary: one pressure solenoid (psol) printed circuit board (pcb) was returned to medtronic for further analysis.A visual inspection of the returned psol pcb shows no anomalies.The psol pcb was assembled into the failure investigation test-bed device and did not pass the power on self test (post).The fault was isolated to component u15.C the cause of the observed condition was determined to be the electronic component failure u15 on psol pcb.The event will be included in trending and monitoring.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.
Additional Manufacturer Narrative
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: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 8908051
• Report Number: 8020893-2019-00158
• Device Sequence Number: 19432324
• Product Code: CBK
• UDI-Device Identifier: 10884521180918
• UDI-Public: 10884521180918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2019

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: 760
• Device Catalogue Number: G-760110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 07/27/2019
• Supplement Date Received by Manufacturer: 08/19/2019; 10/23/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/05/2019; 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1