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

Model Number	740
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the medtronic field service engineer evaluated the ventilator and replaced two pressure solenoid printed circuit board assembly (pcba), power cord and positive end-expiratory pressure (peep) solenoid.After servicing, the ventilator passed all testing per manufacturer specifications and was returned to the customer.All replaced components were returned to medtronic for failure investigation.The returned power cord was visual inspection and functionally tested with no anomalies observed.Conclusion: there was no fault found.There was no malfunction or product deficiency identified.Two pressure solenoid pcbas were visually inspected and functionally tested.One of the pressure solenoids had no fault found.The second pressure solenoid showed that the cylindrical metal tube was detached from component pt3.It is unknown and unreported how this damage occurred.The psol pcb was attached to the failure investigation ventilator for analysis.The ventilator powered on with no errors recorded in the diagnostic logs of the test ventilator.Calibration was performed without any errors.While running the extended self test, the test did not pass the leak test.The fault was isolated to component pt3.The peep solenoid was returned and is under evaluation.Once the investigation is complete, a follow medwatch report will be submitted with the findings.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during preventative maintenance, the 740 ventilator experienced oxygen (o2) solenoid pressure errors and did not pass the extended self test (est) due to a leak.The ventilator was not in use on a patient at the time of the reported event. .
Additional Manufacturer Narrative
Device evaluation summary: the positive end-expiratory pressure (peep) solenoid (exhalation solenoid) was returned for failure investigation.A visual inspection was carried out on the returned part with no anomalies observed.The exhalation solenoid was assembled into the failure investigation test ventilator for analysis.The test ventilator powered on and during testing the test ventilator failed the ¿leak test¿.The part was returned to the vendor, solenoid solutions inc., for root cause analysis.Their findings were as follows, ¿upon disassembly there was seen a small amount of contamination around the upper seal inside of the valve which could have been preventing the seal from making complete contact¿.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,ie
• MDR Report Key: 8552769
• Report Number: 8020893-2019-00095
• Device Sequence Number: 373382
• Product Code: CBK
• UDI-Device Identifier: 10884521078369
• UDI-Public: 10884521078369
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K990897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 03/27/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1