MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the oxygen (o2) sensor on a 980 ventilator failed calibration.Although requested, it is unknown if the patient was connected to the ventilator at the time of the reported event.The service engineer (se) inspected the device and verified the reported issue.The se replaced the o2 sensor.The se performed calibrations and extended self-testing on the device and all tests passed.
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 reported event.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6785871
• Report Number: 8020893-2017-07375
• Device Sequence Number: 13732125
• Product Code: CBK
• UDI-Device Identifier: 10884521171619
• UDI-Public: 10884521171619
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K131252
• 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): 10/30/2017

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: 980
• Device Catalogue Number: 980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1