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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 Communication or Transmission Problem (2896)
Health Effect - Clinical Codes No Patient Involvement (2645); No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that, an 840 ventilator had a loss of communication between the graphic user interface (gui) display and the breath delivery unit (bdu).Patient involvement information was not provided.The service engineer (se) verified the issue and replaced the breath delivery unit (bdu) printed circuit board (pcb) the graphic user interface (gui) pcb and the breath delivery (bd) to graphical user interface (gui) cable.The unit passed all testing and operates within the manufacturing specifications.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The ventilator was not in use on a patient at the time of the event.
 
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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 Key6610809
Report Number8020893-2017-06389
Device Sequence Number531276
Product Code CBK
UDI-Device Identifier10884521180994
UDI-Public10884521180994
Combination Product (Y/N)N
Initial Reporter CountryFR
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) 12/14/2017
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 Number10049979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Initial Date Received by Manufacturer 05/12/2017
Supplement Date Received by Manufacturer12/14/2017
Initial Report FDA Received Date06/05/2017
Supplement Report FDA Received Date12/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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