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

Model Number	980X1ENNISB
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during use on a patient, this 980 ventilator shut down.Although the customer reported ventilator shutdown, a review of system diagnostic logs confirms that the device entered into backup ventilation at the time of the reported event.The device was available for evaluation.The medtronic field service engineer (fse) inspected the device and found the unit had entered backup ventilation.Fse could not confirm evidence that the ventilator shutdown additionally while performing the est (extended self test) and additional error code was generated.The fse replaced an exhalation valve assembly.The ventilator passed all testing per manufacturer specifications at the time of service.The likely cause of the event was isolated in the field to a potential fault in exhalation valve assembly.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use on a patient, this 980 ventilator shut down.The patient was removed from the ventilator and placed on an alternate ventilator with no injury reported.Although the customer reported ventilator shutdown, a review of system diagnostic logs confirms that the device entered into backup ventilation 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 ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: kelly adams ; 2101 faraday ave.; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 14593839
• Report Number: 8020893-2022-00100
• Device Sequence Number: 5811042
• Product Code: CBK
• UDI-Device Identifier: 10884521171749
• UDI-Public: 10884521171749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 980X1ENNISB
• Device Catalogue Number: 980X1ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown