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

Model Number	4-840120DIUU-US
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the customer evaluated the ventilator but could not reproduce reported issue.The customer identified a relevant diagnostic code, referenced service manual and replaced the inspiratory module printed circuit board assembly as a precaution.The ventilator passed all testing and ran on test lung for 16 hours.If the replaced part is returned for failure of investigation, a supplemental med watch report with the findings will be submitted once the investigation is complete.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 and while draining water from the circuit, the 840 ventilator went into an inoperable condition and stopped delivering breaths.The patient was removed from the ventilator and manually ventilated via an ambu bag before being placed on an alternate ventilator with no harm or injury.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; IE
• MDR Report Key: 10569772
• Report Number: 8020893-2020-00155
• Device Sequence Number: 11504080
• Product Code: CBK
• UDI-Device Identifier: 10884522019354
• UDI-Public: 10884522019354
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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: 4-840120DIUU-US
• Device Catalogue Number: 4-840120DIUU-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 121