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

Model Number	4-840220DRAC-GR
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the medtronic service engineer (se) evaluated the device and replaced the transducer printed circuit board (pcb) based on codes reported post event.The ventilator passed all testing per manufacturing specification at the time of service, and was returned to the customer.There is no evidence from the codes reported from the time of the event or service manual documentation on the codes that the ventilator would have stopped ventilation during this event.The cause of the reported event could not be established.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, the 840 ventilator generated a system error message.It was also reported that the unit failed and ventilation did not take place.The patient was removed from the ventilator, and placed on an alternate ventilator with no harm or injury.This event is being conservatively filed as customer reported that there was a loss of ventilation during the event, however, there is no evidence from the codes reported, or service manual documentation on the codes that the ventilator would have stopped ventilation during this event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; IE
• MDR Report Key: 10820395
• Report Number: 8020893-2020-00181
• Device Sequence Number: 14484058
• Product Code: CBK
• UDI-Device Identifier: 10884521077188
• UDI-Public: 10884521077188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: 4-840220DRAC-GR
• Device Catalogue Number: 4-840220DRAC-GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR