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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 Code No Patient Involvement (2645)
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).The ventilator was not in use on a patient at the time the malfunction occurred.The service engineer (se)verified the malfunction and replaced the breath delivery unit (bdu) printed circuit board (pcb), the graphical user interface (gui) pcb, the backlight inverter pcbs, and software was updated to the current revision.The unit passed all testing and operates within the manufacturing specifications.
 
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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 Key6583539
Report Number8020893-2017-06191
Device Sequence Number616435
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
Report Date (Section B) 04/25/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/25/2017
Initial Report FDA Received Date05/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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