MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	4-840120DIJJ-JP
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter information and patient information cannot be provided due to the restriction by the japan privacy regulation.Section e.Japan medtronic personnel reported event to manufacturer on behalf of the customer.Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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, the screen of this 840 ventilator suddenly blacked out and ventilation stopped when the safety valve opened.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Correction to section h6 evaluation code method, result and conclusion codes.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in used on a patient the pb840 ventilator's screen suddenly blacked out and ventilation stopped when the safety valve opened.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue.And replaced the bdu (breath delivery unit) cpu (central processing unit) pcba (printed circuit board assembly), ai (analog interface) pcb and ac (alternating current) power cord.The unit passed all tests and calibrations as per manufacturer specifications at the time of service.The likely cause of the event was isolated in the field to a potential fault the bd cpu pcba, ai pcb and/or ac power cord.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.
Additional Manufacturer Narrative
Section d9 was updated due to part return section h6 evaluation code result additional code added component code remove g07001 and add g02005 h3 device evaluation summary: updated due to part return medtronic conducted an investigation based upon all information received.It was reported that while in used on a patient the pb840 ventilator's screen suddenly blacked out and ventilation stopped when the safety valve opened.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue.And replaced the breath delivery unit (bdu) central processing unit (cpu) printed circuit board assembly (pcba), analog interface (ai) pcb and alternating current (ac) power cord.The unit passed all tests and calibrations as per manufacturer specifications at the time of service.One bd cpu pcba and ac power cord were returned to medtronic for failure investigation.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.One ai pcb was returned to medtronic for failure investigation.A visual inspection was carried out on the returned component and no anomalies were observed.The ai pcb was attached to test ventilator and powered up.The unit failed to power on and the fault was isolated to component diode (d5) of the ai pcb.If d5 were to fail it would have the same effect as switching off the ventilator and causing the ventilator to power off with alarm.The cause of the reported event was isolated to a fault in the diode(d5) of ai pcb.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.The event is included in a data monitoring plan.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: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; michael collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15836115
• Report Number: 8020893-2022-00210
• Device Sequence Number: 14893466
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: 10884521076891
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: 4-840120DIJJ-JP
• Device Catalogue Number: 4-840120DIJJ-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 11/09/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/22/2022; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2011
• 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