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

Model Number	740
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was turned on and the power supply was smoked.The service engineer installed a new power supply.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 740 ventilator after turning on the device "power supply smoked".The ventilator was not in use on a patient at the time of the reported event. .
Additional Manufacturer Narrative
Device evaluation summary: the replaced power supply was returned to medtronic for analysis.It was observed that there was thermal damage on the printed circuit board (pcb), which is the likely cause of the reported condition.The power supply that was returned is now obsolete and no schematics, design files or replacement parts were available so no further investigation was possible.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description

• Brand Name: 740 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 7794147
• Report Number: 8020893-2018-00376
• Device Sequence Number: 1143903
• Product Code: CBK
• UDI-Device Identifier: 10884521078369
• UDI-Public: 10884521078369
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 10/17/2018

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: 09/14/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1