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

Model Number	980U1ESDIUU
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report was not provided.Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while using the 980 ventilator, a patient developed a pneumothorax.Although requested, no further information was provided.The device was available for evaluation.A review of the system logs showed no malfunction of the ventilator.The medtronic service engineer (se) inspected the device and was unable to duplicate the reported issue.The ventilator passed all testing per manufacturing specification and was returned to the customer.This event is being conservatively reported due to the pneumothorax.The cause of the reported event could not be determined without additional information regarding patient history, patient baseline and ventilator settings.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 while using the 980 ventilator, a patient developed a pneumothorax.Although requested, no further information was not provided.Although the ventilator memory logs showed no malfunction of the ventilator, this event is being conservatively reported due to the pneumothorax.
Additional Manufacturer Narrative
Additional information added to investigation summary: the service personnel (sp) inspected the ventilator and found no faults with the unit.Sp visually inspected the unit and found no anomalies.Sp performed est (extended self-test) and found no faults in the unit.Review of the ventilator memory logs showed no malfunction.The unit could not cause a pneumothorax in this scenario.However, this event was conservatively reported due to the pneumothorax.The ventilator passed all testing per manufacturing specification and was returned to the customer.The investigation found the device to function normally.A review of the device history record / product history record identified that the assembly/device had no failures which were relevant to the failure reported by the field.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 12077630
• Report Number: 8020893-2021-00097
• Device Sequence Number: 14343739
• Product Code: CBK
• UDI-Device Identifier: 10884521201422
• UDI-Public: 10884521201422
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 980U1ESDIUU
• Device Catalogue Number: 980U1ESDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown