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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 Mechanical Problem (1384)
Health Effect - Clinical Code No Patient Involvement (2645)
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 a hard keyboard.The ventilator was not in use on a patient at the time of the reported condition.To resolve the issue, a service engineer (se) replaced the keyboard.The unit passed all testing and operates within the manufacturing specifications.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key6556564
Report Number8020893-2017-06035
Device Sequence Number10989285
Product Code CBK
UDI-Device Identifier10884521077102
UDI-Public10884521077102
Combination Product (Y/N)N
Initial Reporter CountryPO
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) 11/07/2017
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-PR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2017
Initial Date Received by Manufacturer 04/12/2017
Supplement Date Received by Manufacturer11/02/2017
Initial Report FDA Received Date05/10/2017
Supplement Report FDA Received Date11/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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