MAUDE Adverse Event Report: COVIDIEN 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	740
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the field service engineer (fse) evaluated the ventilator and replaced the pcba (printed circuit board assembly).While on-site, the fse found the ventilator failed the leak test and replaced the exhalation valve to resolve the additional issue observed.Ventilator passed all testing per manufacturer's specification and was returned to the customer for clinical use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ventilator became inoperable while on a patient.The patient was removed from the ventilator and placed on an alternate ventilator.There was no adverse event or consequences as a result of the reported event.
Additional Manufacturer Narrative
Device evaluation summary: the controller printed circuit board assembly (pcba) was returned for failure investigation.No anomalies were observed upon visual inspection.The part was attached to a test ventilator, and passed all functional tests without generating errors or alarms.Conclusion: no fault found - the cause of the failure could not be determined as the returned controller pcba was found to function normally.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the exhalation valve assembly was returned to medtronic for failure investigation.A visual inspection was carried out on the returned exhalation valve assembly, no anomalies were observed.The exhalation valve assembly was assembled into the failure investigation test ventilator for analysis.The ventilator was powered on and passed the power on self test with no errors recorded in the diagnostic logs.During the extended self test (est), the ventilator failed the "leak test".The fault was isolated to the exhalation valve assembly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 740 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins rd mervue; galway
• MDR Report Key: 7444240
• Report Number: 8020893-2018-00191
• Device Sequence Number: 1094652
• Product Code: CBK
• UDI-Device Identifier: 10884521078369
• UDI-Public: 10884521078369
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K990897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2018

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: 740
• Device Catalogue Number: G-061792-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 06/28/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/15/2018; 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1