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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
Device Problem Occlusion Within Device (1423)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2017
Event Type  malfunction  
Event Description
It was reported an 840 ventilator had an alarm indicating severe occlusion.There was no patient involvement at the time of the reported event.A non-medtronic/covidien service provider inspected the device and confirmed the reported problem.The service provider replaced the expiratory filter.The unit passed all testing and operated within the manufacturer's specifications.Medtronic/covidien was not authorized to repair the device.
 
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Brand Name
840 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
Manufacturer (Section G)
COVIDIEN
micheal collins rd mervue
galway
Manufacturer Contact
ray maroofian
2101 faraday ave
carlsbad, CA 92008
7606035334
MDR Report Key6677141
MDR Text Key78700483
Report Number8020893-2017-06790
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10884521077133
UDI-Public10884521077133
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K970460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/12/2017
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
Device Operator Health Professional
Device Model Number840
Device Catalogue Number4-840220DIUA-EN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/12/2017
Initial Date FDA Received06/29/2017
Date Device Manufactured07/02/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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