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

Model Number	G-760110DIUU-JP
Medical Device Problem Codes	Infusion or Flow Problem (2964); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.The service pers onnel (sp) inspected the ventilator and replaced the pressure solenoid printed circuit board (pcb).The ventilator passed all testing per manufacturer specifications at the time of service.The pressure solenoid pcb was returned to medtronic for further evaluation.Visual inspection noted track damage and contamination /burn marks around component u31 and c12.It was reported that during maintenance, the 760 ventilator generated an oxygen(o2) supply low pressure alarm even though the o2 pipe was connected.The reported issue was confirmed.The most likely cause was related to c omponents on the pressure solenoid pcb; however, it is unknown how this damage occurred.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during maintenance, the 760 ventilator generated an oxygen(o2) supply low pressure alarm even though the o2 pipe was connected.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11136152
• Report Number: 8020893-2021-00004
• Device Sequence Number: 896941
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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-760110DIUU-JP
• Device Catalogue Number: G-760110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1