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 Information (3190)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer inspected the device and the ventilator did not pass power on self-testing (post) and a loss of breath deliver communication error was found in the ventilator memory logs.The service engineer replaced the breath delivery (bd) printed circuit board (pcb).The ventilator passed all testing and was returned to use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, the 840 ventilator stopped operation and started alarming.The patient was transferred to an alternate ventilator without harm or injury.
Additional Manufacturer Narrative
Additional information correction to evaluation codes method, result and conclusion.Correction to the pma / 510k #.Device evaluation summary: the breath delivery (bd) printed circuit board (pcb) was returned for failure investigation.A visual inspection was carried out on the returned component, no anomalies were observed.The bd pcb was attached to the failure investigation test ventilator for analysis.The ventilator ran successfully in ventilation mode for 24 hours.A review of the earlier ventilator diagnostic logs form the event date of 2017 (b)(6) showed a kernal dram test failure on that date.This fault could not be replicated during the 24 hours of testing.The root cause of the observed condition was determined to be the dram device.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: 7166256
• Report Number: 8020893-2018-00008
• Device Sequence Number: 1446659
• Product Code: CBK
• UDI-Device Identifier: 10884521077010
• UDI-Public: 10884521077010
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Followup
• Report Date (Section B): 04/18/2018

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-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1