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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
Information was received indicating that, an 840 ventilator had a faulty graphical user interface (gui) display.The ventilator was not in use on a patient at the time the malfunction occurred.
 
Additional Manufacturer Narrative
The service engineer (se) replaced the graphic user interface (gui) printed circuit board (pcb), upgraded the backlight pcb's, performed calibrations, extended self-testing on the device and all tests passed.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 Key6610346
Report Number8020893-2017-06379
Device Sequence Number788456
Product Code CBK
UDI-Device Identifier10884521077201
UDI-Public10884521077201
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 05/10/2017
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 Number4-840220NISB-EN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Initial Date Received by Manufacturer 05/10/2017
Supplement Date Received by Manufacturer10/05/2017
Initial Report FDA Received Date06/04/2017
Supplement Report FDA Received Date10/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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