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

Model Number	740
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Inoperable (1663)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial notification was submitted though the asr reporting of 1/1/2017 through 3/31/2017 asr approval # e2002003 device evaluation summary: the service engineer (se) troubleshoot the issue, replaced the non-volatile memory (nvram).The se performed calibrations and extended self-testing on the device and all tests passed.A non-volatile memory (nvram) was returned to covidien/ medtronic¿s product analysis.A visual inspection of the component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis; a functional testing was performed.An investigation was performed and the product analysis technician reported that the root cause was isolated to an electronic component.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a 740 ventilator failed the power on self-test (post) and alarmed a vent inoperable.There was no patient involvement at the time of the event.
Additional Manufacturer Narrative
Product analysis: a non-volatile memory (nvram) was returned to covidien/ medtronic¿s product analysis.A visual inspection of the component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis; a functional testing was performed.An investigation was performed and the product analysis technician reported that the root cause was isolated to an electronic component.The initial notification was submitted though the asr reporting of 1/1/2017 through 3/31/2017 asr approval # e2002003.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a 740 ventilator failed the power on self-test (post) and alarmed a vent inoperable.There was no patient involvement at the time of the event.The service engineer (se) troubleshoot the issue, replaced the non-volatile memory (nvram).The se performed calibrations and extended self-testing on the device and all tests passed.

• Brand Name: 740 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; 2101 faraday ave; carlsbad CA 92008
• MDR Report Key: 7046089
• Report Number: 2025525-2017-05000
• Device Sequence Number: 2079739
• Product Code: CBK
• UDI-Device Identifier: 10884521078369
• UDI-Public: 10884521078369
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/20/2017

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: 740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1