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

Model Number	840
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/06/2017
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 an 840 ventilator had an error code dt0002 during post (power on self test).The ventilator was not on a patient at the time of the event.The covidien service engineer (se) inspected the device and replaced the bd pcba (breath delivery-printed circuit board) to correct the issue.The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A breath delivery printed circuit board (pcb) was returned to covidien/medtronic¿s failure analysis laboratory.A visual inspection found no notable conditions.An investigation was performed and the identified root cause of the reported issue could not be duplicated.
Additional Manufacturer Narrative
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: 6598678
• Report Number: 8020893-2017-06295
• Device Sequence Number: 555720
• Product Code: CBK
• UDI-Device Identifier: 10884521076983
• UDI-Public: 10884521076983
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/06/2017

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: 840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 05/06/2017
• Supplement Date Received by Manufacturer: 08/16/2017; 07/17/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/14/2017; 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1