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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 06/27/2017
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 an 840 ventilator had an oxygen sensor that would not calibrate.The ventilator was not in use on a patient at the time of the reported event.The service engineer replaced the oxygen sensor to address the issue.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 Key6743947
Report Number8020893-2017-07108
Device Sequence Number10910309
Product Code CBK
UDI-Device Identifier10884521077041
UDI-Public10884521077041
Combination Product (Y/N)N
Initial Reporter CountryRS
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) 06/27/2017
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-RS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/27/2017
Initial Report FDA Received Date07/26/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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