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	Dyspnea (1816); Tachycardia (2095); Low Oxygen Saturation (2477)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: omeprazole sodium 40mg iv -compound amino acid injection (18aa-) 250mg -xueshuantong injection 250mg -xuebijing injection.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 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 generated a "hardware fault alarm", loss of bd (breath delivery) communication diagnostic code then stopped operating.The device was not available for evaluation.The reported issue was addressed by non-medtronic personnel.It was reported that the customer confirmed the issue and performed the repair on the ventilator.It was also informed that the potential cause of the issue is bdu mainboard failure.No product was returned or made available to medtronic therefore; failure confirmation, cause, or relationship to the event could not be determined.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, this 840 ventilator generated a "hardware fault alarm", loss of bd (breath delivery) communication diagnostic code then stopped operating.The patient experienced difficulty of breathing with a decreased oxygen saturation of 85%.The electrocardiogram (ecg) showed an accelerated heart rate.The patient was manually ventilated with a "respiratory balloon" and placed on an alternate ventilator resulting in improvement of the patient's condition and no permanent harm or injury to the patient.

• 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: 18994246
• Report Number: 8020893-2024-00121
• Device Sequence Number: 14225310
• 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
• Report Date (Section B): 03/28/2024

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: 02/28/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 89 YR
• Patient Sex: Female