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

Model Number	840
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
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 system error alarm while in use on a patient.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the event.The service engineer (se) verified the malfunction and replaced the graphical user interface (gui) printed circuit board (pcb) and upgraded the two inverter backlights.The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
"the service engineer (se) verified the malfunction and replaced the graphical user interface (gui) printed circuit board (pcb) and upgraded the two inverter backlights.The unit passed all testing and operates within the manufacturing specifications." to "the service engineer (se) verified the malfunction and replaced the graphical user interface (gui) printed circuit board (pcb) and upgraded the two inverter backlights.The breath delivery (bd) pcb was also replaced.The unit passed all testing and operates within the manufacturing specifications." 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
The service engineer (se) verified the malfunction and replaced the graphical user interface (gui) printed circuit board (pcb) and upgraded the two inverter backlights.The breath delivery (bd) pcb was also replaced.The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
An investigation was performed and the technician found that the reported problem could not be duplicated.No failure was detected.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: 6518514
• Report Number: 8020893-2017-05809
• Device Sequence Number: 712997
• Product Code: CBK
• UDI-Device Identifier: 10884521181014
• UDI-Public: 10884521181014
• 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
• Report Date (Section B): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 10049984
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided; 06/04/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 06/06/2017; 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention