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 Codes	High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Low Oxygen Saturation (2477)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device evaluation summary: medtronic conducted an investigation based upon all 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, this 840 ventilator suddenly alarmed, indicating a hardware failure and inability to ventilate.The ventilator was not made available to medtronic for evaluation.The customer service staff had performed the extended self test (est) and made the unit work normally.With the information available, the cause of the reported event could not be determined.Further action was not required because the event is included in a data monitoring 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.
Event or Problem Description
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, these 840 ventilators suddenly alarmed, indicating a hardware failure and inability to ventilate.The patient¿s blood pressure increased, heart rate accelerated, and oxygen saturation dropped to 80%.The patient was removed from the ventilator, and oxygen was administered via a nebulized mask, resulting in improved oxygenation; oxygen saturation increased to 99%, blood pressure was 115/56 mmhg, heart rate was 85 bpm, and respiratory rate was 21 breaths per minute.The patient was then placed on an alternate ventilator without injury.

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23609331
• Report Number: 8020893-2025-00264
• Device Sequence Number: 21193324
• Product Code: CBK
• UDI-Device Identifier: 10884521077133
• UDI-Public: (01)10884521077133(11)220322
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 10/24/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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: 72 YR
• Patient Sex: Male