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

Model Number	980
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medtronic service engineer evaluated the ventilator but was unable to duplicate the reported issue.Additionally, the ventilator logs were downloaded and reviewed but no findings related to the reported incident.The ventilator passed all testing per manufacture's specifications and was returned to the customer for clinical use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 980 ventilator was being used on a patient in volume control plus mode with the volume set to 390ml.The patient was successfully weaned from volume control plus to pressure support; however, within a few minutes the tidal volume began to read 3000 ml to 6000 ml without any alarms.The patient was placed on an alternate ventilator with no patient harm.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 8360087
• Report Number: 8020893-2019-00034
• Device Sequence Number: 1789226
• Product Code: CBK
• UDI-Device Identifier: 10884521592810
• UDI-Public: 10884521592810
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1