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

Model Number	840
Medical Device Problem Code	Tidal Volume Fluctuations (1634)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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 incorrect tidal volume.Patient involvement is unknown.The service engineer inspected the device and replaced the exhalation flow sensor and exhalation valve to correct the issue.The unit passed all testing and operated within the manufacturing specifications.
Additional Manufacturer Narrative
An exhalation flow sensor and exhalation valve were returned to covidien/medtronic¿s product analysis.A visual inspection of the re turned components was performed, no notable conditions were found.The returned components were installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs.An investigation was performed and the product analysis technician reported that no fault was found on exhalation valve.The exhalation flow sensor reported issue was isolated to contamination on the hot film elements probable of customer mishandling.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that the ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6755829
• Report Number: 8020893-2017-07227
• Device Sequence Number: 103179
• 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,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

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: 10049984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1