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

Model Number	840
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	07/24/2017
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 that was out of range.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.A medtronic service engineer inspected the device and duplicated the reported condition.The oxygen sensor needed to be replaced.Repair has not been completed at this time.
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.The oxygen o2 sensor was replaced and the ventilator was found to be in working condition.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6811637
• Report Number: 8020893-2017-07563
• Device Sequence Number: 132154
• Product Code: CBK
• UDI-Device Identifier: 10884521181168
• UDI-Public: 10884521181168
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/13/2017

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: 4-076326-00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1