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

Model Number	980
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the service engineer (se) inspected the device, reviewed the logs and verified the reported issue.The se replaced the pneumatic interface printed circuit board assembly (pcba).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced part is returned for failure investigation, a supplement medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a 980 ventilator had a "system failure" error code.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Device evaluation summary: the pneumatic interface printed circuit board was returned for failure investigation.The part was visually inspected and functionally tested with no anomalies observed.Conclusion: there was no fault found.There was no malfunction or product deficiency identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 7836839
• Report Number: 8020893-2018-00415
• Device Sequence Number: 11347015
• Product Code: CBK
• UDI-Device Identifier: 10884521171602
• UDI-Public: 10884521171602
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 03/06/2019

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: 980X1ITDIEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1