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

Model Number	760
Medical Device Problem Codes	Failure to Power Up (1476); No Flow (2991)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Code Available (3191)
Date of Event	08/14/2018
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 setting up on a patient the 700 series ventilator had passed post(power on self test) with an error message indicating " it could not be used".Ventilation stopped.Immediately another ventilator was prepared and it was used.No harm was reported.
Additional Manufacturer Narrative
Additional information received and event description updated.Correction to patient code and device code.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received as follows: it was reported that during setting up the 700 series ventilator passed post (power on self-test) with an error message "it could not be used".The patient was not attached to the ventilator at the time of the event.Immediately another ventilator was prepared, and it was used.No harm was reported.
Additional Manufacturer Narrative
Device evaluation summary: one pressure solenoid (psol) printed circuit board (pcb) was returned to medtronic for further analysis.A visual inspection was carried out and no anomalies were observed.The psol pcb was assembled into the failure investigation test-bed device for analysis and the device was powered on.The fi test-bed device passed the power on self test (post) and no errors were recorded in the diagnostic logs.All tests and calibrations ran without any errors.The fi test-bed device was placed into ventilation mode for 24 hours, no errors/alarms observed the run in period.Conclusion: no fault found.The investigation found the device to function normally.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 7839994
• Report Number: 8020893-2018-00416
• Device Sequence Number: 16430004
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2019

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: 760
• Device Catalogue Number: G-760110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/18/2018; 10/22/2019
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/25/2018; 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1