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

Model Number	4-840120DICU-EN
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information cannot be provided due to the canada personal health information protection act.Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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 (b)(4) ventilator shut off.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Patient information cannot be provided due to (b)(6).Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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 840 ventilator shut off.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Additional information: section b5 description event problem updated 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
Additional information received as follows: it was reported that while in use on a patient, the 840 ventilator generated an alarm and shut off.The ventilator did not continue to deliver breaths to the patient.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Additional information added to section a correction to section h6 evaluation code method and result.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the pb840 ventilator generated an alarm and shut off.The device was available for evaluation.The service personnel (sp) inspected the ventilator and could not confirm the reported issue that the ventilator stopped ventilation but found other faults.The sp checked and found the gui (graphic user interface) display does not turn on, the gui led array flashing test failed and unexpected reset umpire test.To solve this issue sp replaced the gui cpu (central processing unit) pcba (printed circuit board assembly) along with two backlight inverters.The identified secondary issue is not related to the reported issue and would not a cause loss of ventilation or the ventilator to shut off.The ventilator passed all required testing per manufacturer specifications and was returned to the customer.The investigation could not confirm the reported issue but found a faulty with the gui cpu pcba, as secondary issue.A cause to the reported issue was not 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.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.
Additional Manufacturer Narrative
H3 device evaluation summary: updated due to part return it was reported that while in use on a patient, the pb840 ventilator generated an alarm and shut off.The service personnel (sp) inspected the ventilator and could not confirm the reported issue that the ventilator stopped ventilation but found other faults.The sp checked and found the gui (graphic user interface) display does not turn on, the gui led array flashing test failed and unexpected reset umpire test.To solve this issue sp replaced the gui cpu (central processing unit) pcba (printed circuit board assembly) along with two backlight inverters.The identified secondary issue is not related to the reported issue and would not a cause loss of ventilation or the ventilator to shut off.The ventilator passed all required testing per manufacturer specifications and was returned to the customer.If a display issue were to occur during patient use, the healthcare provider is unable to monitor the device settings or patient data.The ventilator will continue to deliver breaths to the patient with the existing settings.Any patient related alarm condition, subsequent to the display issue, will generate an audible and visual indication of the alarm priority.One gui pcba was returned to medtronic for further analysis.The returned part was attached to the test ventilator and powered up.Analysis found unit failed post generating a gui inop condition.The gui display screen was blank and diagnostic code unexpected reset umpire was displayed on the gui diagnostic led array.Analysis isolated the fault to the vga controller, reference designator u34.Analysis determined returned gui pcba faulty.The investigation could not confirm the reported issue but found fault in gui cpu pcba, as secondary issue.A cause to the reported issue was not 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.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; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 13529654
• Report Number: 8020893-2022-00030
• Device Sequence Number: 17200512
• Product Code: CBK
• UDI-Device Identifier: 10884521076877
• UDI-Public: 10884521076877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2022

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: 4-840120DICU-EN
• Device Catalogue Number: 4-840120DICU-EN
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 02/16/2022; 04/21/2022; 11/09/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/11/2022; 04/27/2022; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2009
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 66 KG