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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 Type  malfunction  
Event Description
It was reported that an 840 ventilator had an occluded safety valve during testing.The ventilator was not in use on a patient at the time of the reported event.A service engineer (se) inspected the device and they replaced the safety valve.The unit passed all testing and operates within the manufacturing specifications.
 
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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 Key6556541
MDR Text Key74831264
Report Number8020893-2017-06034
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10884521181021
UDI-Public10884521181021
Combination Product (y/n)N
Reporter Country CodePO
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 04/12/2017
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 Number10049985
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Initial Date Manufacturer Received 04/12/2017
Initial Date FDA Received05/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2014
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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