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

Model Number	740
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer evaluated the ventilator and replaced the pressure solenoid (psol) printed circuit board (pcb), controller pcb and the exhalation valve.Additionally the software was updated.The device passed all testing per manufacturer specification and was returned to the customer.The following components were returned for failure investigation: controller pcb, psol pcb both components were visually inspected with no anomalies observed.The controller pcb was functionally tested with no malfunction or product deficiency identified.Upon performing device evaluation, the psol pcb failed the power on self test (post); the fault was isolated to component u31.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 740 ventilator failed the power on self test (post).There was no patient involvement with the reported event.

• Brand Name: 740 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 8081812
• Report Number: 8020893-2018-00546
• Device Sequence Number: 1527440
• Product Code: CBK
• UDI-Device Identifier: 10884521180970
• UDI-Public: 10884521180970
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 11/16/2018

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-061949-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1