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, during testing, a 980 ventilator generated a power on self-test (post) error code.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) evaluated the ventilator and verified the reported issue.The flow valve needed to be replaced.The evaluation and repair of the device has not been completed.
Additional Manufacturer Narrative
Additional information was received on 2017-jul-11 regarding repairs.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, during testing, a 980 ventilator generated a power on self-test (post) error code.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) inspected the ventilator and replaced the delivery proportional solenoid (psol).The unit passed all testing and operated within the manufacturing specifications.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6695119
• Report Number: 8020893-2017-06877
• Device Sequence Number: 19144265
• Product Code: CBK
• UDI-Device Identifier: 10884521171619
• UDI-Public: 10884521171619
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 06/08/2017

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?: No
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1