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 Code Available (3191)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After the unit was removed from usage, the ventilator was found to not pass the power on self-test (post).A service engineer (se) inspected the device and replaced the graphical user interface (gui) to breath delivery (bd) cable with a provisory one.The unit passed testing and operated within the manufacturing specifications.Once the definitive cable is available, the part will be installed.Should the replaced component be returned to the manufacturing site, an additional evaluation will be performed and a supplemental report will be submitted.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 ventilating.The patient was placed on an alternate ventilator and there were no significant consequences to the patient as a result of the event.
Additional Manufacturer Narrative
Additional information received as follows: after the ventilator was removed from usage, the ventilator was found to not pass the power on self-test (post).The service engineer replaced the breath delivery (bd) central processing unit printed circuit board.Additionally the provisory bd cable was replaced with the definitive cable.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
On 2018-dec-04 it was identified that a correction needed to be made to the device evaluation summary.Corrected "the service engineer replaced the breath delivery (bd) central processing unit printed circuit board.Additionally the provisory bd cable was replaced with the definitive cable" to "a service engineer (se) inspected the device and replaced the breath delivery (bd) central processing unit (cpu) printed circuit board (pcb) and ventilator arm.Additionally, the provisory bd cable was replaced with a definitive cable.The unit passed testing and operated within the manufacturing specifications." if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the gui to bd cable assembly was returned to medtronic for failure investigation.The component was visually inspected and functionally tested with no malfunction or product deficiency identified.The bd cpu pcb was also returned to medtronic for failure investigation.A visual inspection of the returned component revealed no anomalies.The component was attached to the failure investigation test ventilator for analysis.The ventilator powered up normally with no errors recorded in the diagnostic logs.All pre-use testing was performed successfully.The ventilator was placed in normal ventilation mode and ran for a period of time and then generated a "vent inop" condition.The fault was isolated to the alliance manufactured dram device.Alliance manufactured devices were discontinued and replaced by oki manufactured devices for new bd pcbs from 2005-mar-14 due to higher reliability of the oki dram devices than the alliance parts.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: 7915914
• Report Number: 8020893-2018-00474
• Device Sequence Number: 19025307
• Product Code: CBK
• UDI-Device Identifier: 10884521077102
• UDI-Public: 10884521077102
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K151252
• 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): 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840220DIPC-PR
• 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: 09/04/2018
• Supplement Date Received by Manufacturer: 10/15/2018; 12/04/2018; 01/17/2019
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/26/2018; 12/05/2018; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 70