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

Model Number	4-840220DIUA-EN
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the china food and drug administration (cfda), adverse reaction event center of (b)(6), and not reported directly to medtronic by the customer that while in use on a patient, the 840 ventilator shut down.The patient was removed from the ventilator then was immediately provided with manual air and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section a patient information some information cannot be provided due to china's personal information protection law h3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Section d8 updated section h6 evaluation codes updated due to additional information received.Method code (annex b) additional code added result code (annex c) remove c20 and add c13 conclusion code (annex d) remove d15 and add d02 component code (annex g) remove g07003 and add g03012 h3 additional information received: it was reported by the china food and drug administration (cfda), adverse reaction event center of shanghai, and not reported directly to medtronic by the customer that while in use on a patient, the pb840 ventilator shut down.The repair/evaluation for the reported issue was performed by non-medtronic personnel.It was informed that the hospital staff (cust omer) determined the exhalation flow sensor had failed resulting in the ventilator shutting down.The customer reported the exhalation flow sensor failure was potentially related to the use of an electronic nebulizer with the ventilator the cause of the event was isolated to a potential fault in the exhalation flow sensor.The event is included in the trending and m onitoring plan.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20346131
• Report Number: 8020893-2024-00343
• Device Sequence Number: 20844664
• Product Code: CBK
• UDI-Device Identifier: 10884521077133
• UDI-Public: 10884521077133
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 4-840220DIUA-EN
• Device Catalogue Number: 4-840220DIUA-EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2019
• 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: Male