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

Model Number	10049998-RFB
Medical Device Problem Codes	No Flow (2991); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.It was reported that this 840 ventilator generated a backg round check bdu (breath delivery unit) diagnostic code.The device was for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue.To solve the issue, sp installed new bd (breath delivery) cpu (central processing unit) and updated software new rev ak.The ventilator passed all tests and calibrations.It is in working condition and has been returned to the customer.One bd pcb was returned for failure investigation.It was installed in the test ventilator and powered up.When the ventilator was put on ventilation, the ventilator generated a ¿vent inop¿ condition with a relevant error cod (bd eeprom checksum error) recorded in the diagnostic logs.The fault was isolated to the bd operating software having become corrupt.The bd software was erased.Software was reloaded to the bd xena ii pcb.It was again installed in the test ventilator and powered up.No errors and no alarms were found.If this failure occurred during ventilation, the ventilator would generate a vent inop condition.The appropriate audio and visual alarms would enunciate.The cause of the observed conditions determined to be faulty bd 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 this 840 ventilator generated a background check bdu (breath delivery unit) diagnostic code. 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
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 14319339
• Report Number: 8020893-2022-00085
• Device Sequence Number: 20118275
• Product Code: CBK
• UDI-Device Identifier: 10884521750548
• UDI-Public: 10884521750548
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: 10049998-RFB
• Device Catalogue Number: 10049998-RFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2018
• 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: Unknown