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

Model Number	980
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 the display on a 980 ventilator was "flickering intermittently" and "faulty".The ventilator was not in use on a patient at the time of the reported event.A service engineer (se) inspected the device and confirmed the reported issue.To address the issue, the ventilator was replaced for another per customer request.
Additional Manufacturer Narrative
Added relevant report sources per provided information; should have been included in initial report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: a 980 ventilator was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned ventilator was performed and found the exhalation flow sensor (evq) seal was missing and no battery was returned.For functionality testing an evq seal and battery were installed into the returned ventilator; no errors were recorded in the diagnostic logs.The customer reported issue was verified.The user interface (ui) printed circuit board (pcb) was removed for further investigation and found to have contamination on multiple locations of the pcb.An investigation was performed and the product analysis technician reported that the root cause was isolated to contamination on the pcb.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; micheal collins rd mervue; galway
• MDR Report Key: 6774267
• Report Number: 8020893-2017-07319
• Device Sequence Number: 590542
• Product Code: CBK
• UDI-Device Identifier: 10884521171565
• UDI-Public: 10884521171565
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 01/12/2018

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: 11/30/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/08/2017; 01/10/2018
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 08/08/2017; 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1