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

Model Number	10049985
Medical Device Problem Codes	No Flow (2991); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during preventative by the medtronic service engineer, the 840 ventilator would not turn on.The device was available for evaluation.The service personnel (sp) inspected the ventilator and replaced two breath delivery (bd) central processing unit (cpu) printed circuit board (pcb) one of which was a failure out of box, graphic user interface (gui) cpu pcb, analog interface (ai) pcb and power supply unit.The ventilator passes all testing per manufacture specification at the time of service.The replaced components were returned to medtronic for further analysis.Each component was analyzed and tested individually in a test ventilator.No faults were found in the power supply, ai pcb and one of the bd cpu pcb.The gui cpu pcb was analyzed and found faulty due to q2 component fault.One bd cpu pcb was analyzed and found faulty due to faulty u101 reference designator.This fault would generate a ventilator inoperative condition.The cause of the event was isolated to a fault in bd cpu pcb & gui cpu pcb.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met 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 during preventative by the medtronic service engineer, the 840 ventilator would not turn on.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• MDR Report Key: 12721374
• Report Number: 8020893-2021-00177
• Device Sequence Number: 19840781
• Product Code: CBK
• UDI-Device Identifier: 10884521181021
• UDI-Public: 10884521181021
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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: 10049985
• Device Catalogue Number: 10049985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1