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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 Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes No Patient Involvement (2645); No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported an 840 ventilator had a faulty oxygen sensor.Although requested, it is unknown if the patient was connected to the ventilator at the time of the reported event.The service engineer replaced the oxygen sensor performed testing and calibrations and the ventilator is in good working condition.
 
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 reported 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 Key6822650
Report Number8020893-2017-07636
Device Sequence Number13467828
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 company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/22/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2017
Initial Date Received by Manufacturer 07/03/2017
Supplement Date Received by Manufacturer11/22/2017
Initial Report FDA Received Date08/25/2017
Supplement Report FDA Received Date11/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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