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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 Calibration Problem (2890)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/21/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that, an 840 ventilator had failed the oxygen sensor calibration.The ventilator was not in use on a patient at the time the event occurred.The covidien service engineer (se) inspected and verified the issue reported, the se replaced the oxygen sensor.The unit passed all testing and operated 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 Key6720093
Report Number8020893-2017-06983
Device Sequence Number992454
Product Code CBK
UDI-Device Identifier10884521076921
UDI-Public10884521076921
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K970460
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/21/2017
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 Number4-840120DIUU-EN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2017
Initial Report FDA Received Date07/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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