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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
Additional Manufacturer Narrative
At this time, covidien/medtronic has not received the suspect device/component from the customer for evaluation.
 
Event or Problem Description
It was reported that an 840 ventilator had a loss of graphical user interface (gui) communication error.The ventilator was not in use on a patient at the time the event occurred.The service engineer (se) replaced the graphical unit interface (gui) printed circuit board (pcb) and upgraded the backlight pcbs.The unit passed all testing and operated within the manufacturing specifications.In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.
 
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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 Key6750768
Report Number8020893-2017-07155
Device Sequence Number1063517
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,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/29/2017
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 Number4-840220DIPC-PL
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/29/2017
Initial Report FDA Received Date07/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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