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

Model Number	980
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, while in use on a patient, a 980 ventilator "had smoke and smell." the patient was removed from the ventilator and was not harmed or injured as a result of the reported event.
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
The patient was removed from the ventilator and placed on an alternate ventilator.
Additional Manufacturer Narrative
Device evaluation summary: the direct current (dc) to dc printed circuit board (pcb) was returned for failure investigation.A visual inspection of the returned part was conducted and it was observed that component c83 had thermal damage.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation code - result.Device evaluation summary: the air/oxygen mix proportional solenoid (psol) was returned for failure investigation.The psol was installed into a failure investigation test ventilator for analysis.The unit failed the mix leak test.A breakdown of the component was performed, no contamination was found.Engineering concluded that the poppet may have moved in an unusual manner inside the psol causing it not to seal correctly resulting in the leak.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: 7111227
• Report Number: 8020893-2017-07819
• Device Sequence Number: 16446900
• Product Code: CBK
• UDI-Device Identifier: 10884521201910
• UDI-Public: 10884521201910
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K162738
• 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,Followup
• Report Date (Section B): 10/23/2018

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: 980A3ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/02/2018; 09/17/2018; 10/19/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/05/2018; 09/19/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1