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

Model Number	4-840120DIUU-US
Medical Device Problem Codes	Defective Alarm (1014); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation device summary: medtronic conducted an investigation based upon all information received.The device was not made available for evaluation.The customer checked logs in service mode and found an "oxygen sensor bad" diagnostic code.Extended self-test (est) and short self-test (sst) was performed and worked fine.The fse taught the customer how to perform oxygen calibration and advised to run the ventilator using the test lung within 24 hours and observe for additional issue.It was reported that while in use on a patient, this 840 ventilator showed "0" vt (tidal volume).Additionally, the ventilator stopped delivering breaths to the patient.There was no alarm generated.The reported issue could not be confirmed.The most likely root cause could not be established from the information available.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.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 840 ventilator showed "0" vt (tidal volume).Additionally, the ventilator stopped delivering breaths to the patient.There was no alarm generated.The ventilator was changed but they think that it was the patient/clinical condition.There was no patient harm.
Additional Manufacturer Narrative
Additional codes added to section h6 device codes and evaluation code method.Component code added.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
• MDR Report Key: 11152115
• Report Number: 8020893-2021-00009
• Device Sequence Number: 19056779
• Product Code: CBK
• UDI-Device Identifier: 10884522019354
• UDI-Public: 10884522019354
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 4-840120DIUU-US
• Device Catalogue Number: 4-840120DIUU-US
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1