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

Model Number	980
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer (se) inspected the device, reviewed the logs and verified the reported issue.The se found a leak, delivery pressure solenoid (psol) stuck open error code.The se replaced the psol.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced part is returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.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 activated backup ventilation.The patient was removed from the vent ilator and placed on an alternate ventilator with no harm or injury.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 7993534
• Report Number: 8020893-2018-00517
• Device Sequence Number: 1411590
• Product Code: CBK
• UDI-Device Identifier: 10884521172876
• UDI-Public: 10884521172876
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 980X3ENDRAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 85