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

Model Number	840
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Patient Involvement (2645)
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, an 840 vent had a severe occlusion alarm.The ventilator was not in use on a patient at the time the event occurred.The covidien service engineer (se) verified the issue.The se inspected the device and replaced the analog interface (ai) printed circuit board (pcb).The unit passed all testing and operated within the manufactures specifications.
Additional Manufacturer Narrative
Evaluation: the analog interface (ai) printed circuit board (pcb) was returned to medtronic¿s product analysis laboratory.A visual inspection was performed and no anomalies were observed.An investigation was performed and the reported issue was not duplicated.No errors were recorded in the diagnostic logs during testing.No fault was found with the returned ai pcb.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.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6747489
• Report Number: 8020893-2017-07134
• Device Sequence Number: 2065131
• Product Code: CBK
• UDI-Device Identifier: 10884521077034
• UDI-Public: 10884521077034
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 06/28/2017

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-IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1