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

Model Number	980
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, medtronic has not received the suspect device/component from the customer for evaluation.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 does not provide the required volume, and during testing, the safety valve of the ventilator failed to open.The customer stated that, although they replaced the filter, exhalation vessel, and flow sensor device membranes, the ventilator still failed testing.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6814254
• Report Number: 8020893-2017-07574
• Device Sequence Number: 11279254
• Product Code: CBK
• UDI-Device Identifier: 10884521171633
• UDI-Public: 10884521171633
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/26/2017

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: 07/26/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1