MAUDE Adverse Event Report: COVIDIEN 760 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	G-061949-00
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: a non-volatile random-access memory (nvram) was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis and functionality testing was performed.When the test ventilator was powered on it failed the power on self-test.An investigation was performed and the product analysis technician reported that the root cause was isolated to an electronic component.The event was originally submitted through the asr reporting e2002003 on 2017-04-13.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The original initial report was submitted through the asr reporting e2002003 on 2017-04-13 at the time of filing follow-up reports, asr was discontinued.The initial is being resubmitted through emdr.Device evaluation summary: the medtronic service engineer (se) inspected the device replaced the non-volatile random access memory (nvram).) the ventilator passed all testing per manufacturer specifications and is ready for use.The nvram was returned to medtronic for further evaluation.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis and functionality testing was performed.When the test ventilator was powered on it failed the power on self-test.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 the ventilator did not pass power on self tests.The ventilator was not on a patient at the time of the event.The service engineer replaced the non volatile random access memory (nvram).The ventilator passed self-testing.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7287721
• Report Number: 8020893-2018-00102
• Device Sequence Number: 13973125
• Product Code: CBK
• UDI-Device Identifier: 10884521180970
• UDI-Public: 10884521180970
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 02/21/2018

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: G-061949-00
• Device Catalogue Number: G-061949-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1