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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 840
Medical Device Problem Code Defective Component (2292)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/23/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that an 840 ventilator had a gui (graphical user interface) latch issue.The ventilator was not on a patient at the time of the event.The service engineer replaced the gui monitor latch to correct the issue.The unit passed all testing and operates within the manufacturing specifications.
 
Additional Manufacturer Narrative
This medwatch report was inadvertently submitted.The issue reported does not meet the criteria of reportability as it could not have caused or contributed to a death or serious injury.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
840 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
MDR Report Key6636891
Report Number8020893-2017-06545
Device Sequence Number96105
Product Code CBK
UDI-Device Identifier10884521077096
UDI-Public10884521077096
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K970460
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/12/2017
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 Number840
Device Catalogue Number840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2017
Initial Date Received by Manufacturer 05/23/2017
Supplement Date Received by Manufacturer12/12/2017
Initial Report FDA Received Date06/13/2017
Supplement Report FDA Received Date12/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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