MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medtronic service engineer evaluated the ventilator and replaced the analog interface (ai) board.After servicing, the ventilator passed all testing per manufacturer specifications and was returned to the customer.The ai board was returned to medtronic for failure investigation.The component was visually inspected with no anomalies observed.The ai board was attached to the failure investigation test ventilator for analysis.The ventilator powered up but did not pass the power on self test generating an alarm and a ventilator inoperative condition.The fault was isolated to a 47-ohm circuit across capacitor reference designator c104.If this fault occurred during ventilation, the ventilator would generate the appropriate audio and visual alarms and enter an inoperative condition, leading to a loss of ventilation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during routine service and repair, the 840 ventilator powered up/down by itself.The ventilator was not in use on a patient at the time of the event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 8451945
• Report Number: 8020893-2019-00068
• Device Sequence Number: 14144659
• Product Code: CBK
• UDI-Device Identifier: 10884521181250
• UDI-Public: 10884521181250
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: 840
• Device Catalogue Number: 10049980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1