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

Model Number	760
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use on patient the 760 ventilator had generated ventilation failure alarm.The device turned on again then post(power on self test) failure occurred with error codes.The patient was removed from the ventilator and placed on an alternate ventilator with no harm or injury.
Additional Manufacturer Narrative
Device evaluation summary: the service personnel (sp) inspected the ventilator and replaced the pressure solenoid (p-sol) board.The ventilator passed all test and calibrations at the time of service and was returned to the customer.One psol was returned to medtronic for further analysis.A visual inspection of the returned psol shows no anomalies.The psol was attached to the failure investigation (f.I) test ventilator and it did not pass the power on self test (post).The fault was isolated to component u38.The cause of the observed condition was determined to be the electronic component failure on the p-sol board.The event will be included in trending and monitoring.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 7916047
• Report Number: 8020893-2018-00476
• Device Sequence Number: 13667134
• Product Code: CBK
• UDI-Device Identifier: 10884521180918
• UDI-Public: 10884521180918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 760
• Device Catalogue Number: G-760110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1