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

Model Number	840
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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 oxygen sensor issue.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.The service engineer replaced the oxygen sensor to address the issue.The unit passed all testing and operated within the manufacturing specifications.
Additional Manufacturer Narrative
An oxygen (o2) sensor was returned to covidien/medtronic¿s product analysis.A visual inspection of the returned component was performed and the connector on the sensor was found to be broken.The o2 sensor installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that the reported issue was isolated to the broken connector on the sensor.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The ventilator was not in use on a patient at the time of the event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6792181
• Report Number: 8020893-2017-07422
• Device Sequence Number: 878264
• 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,Followup
• Report Date (Section B): 11/15/2017

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: 09/06/2017
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 11/15/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 09/26/2017; 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1