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

Model Number	840
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/22/2017
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 had a intermittent reset display while device was in use on a patient.The patient was not harmed or injured as a result of the event.The patient was removed from the ventilator and placed on an alternate ventilator.The covidien technical support engineer (tse) troubleshot this issue with the customer over the phone, and customer was advise to replace the graphic user interface (gui) printed circuit board (pcb) and covidien service engineer will install the operational software.Onsite biomed will complete the repair.Covidien was not authorized to service the device.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6706133
• Report Number: 8020893-2017-06905
• Device Sequence Number: 19121986
• Product Code: CBK
• UDI-Device Identifier: 10884521076990
• UDI-Public: 10884521076990
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970460
• 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
• Report Date (Section B): 06/14/2017

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: 4-840220ASAA-EN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/12/2017
• 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