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

Model Number	4-840220ASAA-EN
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190); No Code Available (3191)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the customer reported that the ventilator has passed performance verification testing (pvt), extended self test (est), and short self test (sst) and ran the ventilator for 2 days.The customer could not duplicate the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported during use the 840 ventilator stopped ventilating and there were no carbon dioxide (co2) readings on the monitor indicating no breathing and the ventilator screen was blank.It was reported that the ventilator was restarted.The ventilator generated a gui (graphic user interface) reset error code.Although requested, it is unknown if the patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received as follows: the patient was transferred to an alternate ventilator without harm or injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7903536
• Report Number: 8020893-2018-00461
• Device Sequence Number: 13494956
• Product Code: CBK
• UDI-Device Identifier: 10884521076990
• UDI-Public: 10884521076990
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151252
• 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): 04/18/2019

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: 4-840220ASAA-EN
• Device Catalogue Number: 4-840220ASAA-EN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 04/17/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/04/2018; 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1