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

Model Number	980
Medical Device Problem Code	Device Displays Incorrect Message (2591)
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 a 980 ventilator generated a constant alarm.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) inspected the device and found a diagnostic code relevant to the reported incident recorded in the ventilators memory logs.The se replaced the exhalation valve flow sensor (evq) and breath delivery unit (bdu) printed circuit board (pcb).The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
A breath delivery (bd) printed circuit board (pcb) was returned to covidien/medtronic¿s product analysis.A visual inspection of the returned components was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs.An investigation was performed and the product analysis technician reported that no fault was found.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: 6760640
• Report Number: 8020893-2017-07253
• Device Sequence Number: 16574775
• Product Code: CBK
• UDI-Device Identifier: 10884521171749
• UDI-Public: 10884521171749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2017

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: 08/30/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1