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

Model Number	G-061949-00
Medical Device Problem Codes	Infusion or Flow Problem (2964); No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the medtronic field service engineer (se) inspected the ventilator and was unable to calibrate oxygen (o2) pressure solenoid and unit locked up while trying to update constants.The se replaced the controller printed circuit board assembly (pcba), nvram, and o2 press transducer.The ventilator passed all test and calibrations per manufacturer specifications at the time of service.One controller pcb was returned to medtronic for further analysis.A visual inspection of the returned board shows no anomalies.The pcb was assembled into the failure investigation (f.I) test ventilator and it successfully passed all tests and calibrations.The pcb tested satisfactorily.One nvram was returned to medtronic for further analysis.A visual inspection of the returned nvram shows no anomalies.The nvram was assembled into the failure investigation (f.I) test ventilator and it failed the power on self test (post) with error codes that could lead to a loss of ventilation if it were to occur while in use on a patient.One o2 pressure transducer was returned to medtronic for further analysis.A visual inspection of the returned part shows no anomalies.The o2 transducer was assembled into the fi test ventilator and it successfully passed all tests and calibrations.The o2 transducer tested satisfactorily.The cause of the observed condition was determined to be electronic component in the nvram.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 760 ventilator failed oxygen flow.The ventilator was not in use on a patient at the time of the reported e vent.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 9438470
• Report Number: 8020893-2019-00227
• Device Sequence Number: 2335603
• Product Code: CBK
• UDI-Device Identifier: 10884521180970
• UDI-Public: 10884521180970
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/09/2019

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: 10/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1