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 had a communication error.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) inspected the device.The se found the display printed circuit board (pcb) and the rotary connector was damaged.The se updated the software to the current revision, performed calibrations and extended self-testing on the device and all tests passed.
Additional Manufacturer Narrative
A display printed circuit board (pcb) was returned to covidien/medtronic¿s failure analysis.A visual inspection noted damage to the status display pcb.An investigation was performed and root cause was isolated to a damaged connector on the status display pcb.It is unknown how the damage occurred to the pcb.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6575411
• Report Number: 8020893-2017-06147
• Device Sequence Number: 1089386
• Product Code: CBK
• UDI-Device Identifier: 10884521172586
• UDI-Public: 10884521172586
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 04/19/2017

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: 04/19/2017
• Supplement Date Received by Manufacturer: 07/14/2017; 07/14/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 08/30/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1