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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 No Display/Image (1183)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that an 840 ventilator had a screen blocked due to being dropped and damaged.The ventilator was not on a patient at the time of the event.The service engineer replaced the gui cpu (graphical user interface central process unit) and backlight inverter 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.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 Key6753946
Report Number8020893-2017-07199
Device Sequence Number13485226
Product Code CBK
UDI-Device Identifier10884521077058
UDI-Public10884521077058
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K970460
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/25/2017
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 Number4-840220DIEC-SP
Was Device Available for Evaluation? No
Date Returned to Manufacturer05/25/2017
Initial Date Received by Manufacturer 05/25/2017
Supplement Date Received by Manufacturer08/17/2017
Initial Report FDA Received Date07/31/2017
Supplement Report FDA Received Date08/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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