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

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer evaluated the ventilator and replaced the analog interface (ai) printed circuit board (pcb) and the breath delivery pcb.The ventilator passed all testing per manufacturer specification and was returned to the customer.Both components were returned to medtronic for failure investigation.The bd pcb was obsolete and was unable to be tested.The ai pcb was visually inspected and no anomalies were observed.The ai pcb was attached to the failure investigation test ventilator for analysis.The ventilator was powered up and all pre-use testing was performed successfully without any errors.The ventilator was placed into a normal ventilation mode.After approximately 33 hours ventilator generated a "vent inop"condition.The fault was isolated to component reference designator u53.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during service the 840 ventilator generated a background fault error 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
• MDR Report Key: 8327859
• Report Number: 8020893-2019-00027
• Device Sequence Number: 16707686
• Product Code: CBK
• UDI-Device Identifier: 10884521077058
• UDI-Public: 10884521077058
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 840
• Device Catalogue Number: 4-840220DIEC-SP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1