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

Model Number	840
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an 840 ventilator had a faulty oxygen sensor.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.The service engineer inspected the device and replaced the o2 sensor.The ventilator passed all testing and operated within the manufacturer's specifications.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use, an 840 ventilator had a faulty oxygen sensor (o2); it had an issue with o2 monitoring.The patient was transferred to another ventilator and there was no harm to the patient as a result of the event.The unit passed testing and operated within the manufacturing specifications.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6719189
• Report Number: 8020893-2017-06968
• Device Sequence Number: 1735979
• Product Code: CBK
• UDI-Device Identifier: 10884521077188
• UDI-Public: 10884521077188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/17/2017

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: 4-840220DRAC-GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1