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

Model Number	840
Medical Device Problem Codes	No Audible Alarm (1019); No Flow (2991)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 840 ventilator had a vent inop alarm failure.Information about patient involvement was not provided.The service engineer (se) evaluated the ventilator and replaced the breath delivery unit (bdu) printed circuit board (pcb) the analog interface (ai) pcb and the exhalation valve.The unit passed all testing and operates within the manufacturer specifications.
Additional Manufacturer Narrative
August/02/2017 new information was provided by the covidien service engineer stating that no patient was involved during the event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Investigation: the replaced analog interface printed circuit board (pcb (ai pcb), breath delivery xena ii pcb (bd xena ii pcb), and exhalation valve were returned for failure investigation.The components were visually inspected and functionally tested.All components were installed into the failure investigation test ventilator for analysis.The ventilator was placed into ventilation mode for a minimum of 24 hours.There were no errors or alarms noted during the testing.Conclusion: no fault found.There was no malfunction or product deficiency identified.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: correction:device code, if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 840 ventilator generated a ventilator inoperative (inop) alarm.The ventilator was not in use on a patient at the time of the event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6758201
• Report Number: 8020893-2017-07236
• Device Sequence Number: 11115820
• Product Code: CBK
• UDI-Device Identifier: 10884521077058
• UDI-Public: 10884521077058
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/25/2019

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: 09/06/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017; 09/18/2017; 01/08/2019
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 08/02/2017; 09/26/2017; 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1