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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 Device Inoperable (1663)
Health Effect - Clinical Codes No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the ventilator generated an error which rendered the ventilation inoperable.There was no patient harm reported.
 
Additional Manufacturer Narrative
The service engineer (se) inspected the ventilator and replaced the expiratory pressure transducer auto-zero solenoid (sol2).The unit passed testing and operated within the manufacturing specifications.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
new mervue industrial park
micheal collins rd mervue
galway
MDR Report Key6457252
Report Number8020893-2017-05541
Device Sequence Number614951
Product Code CBK
UDI-Device Identifier10884521077188
UDI-Public10884521077188
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,Followup
Report Date (Section B) 03/08/2017
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 Number4-840220DRAC-GR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2017
Initial Date Received by Manufacturer 03/08/2017
Supplement Date Received by Manufacturer03/14/2017
Initial Report FDA Received Date04/04/2017
Supplement Report FDA Received Date10/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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