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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR
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COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR Back to Search Results
Model Number 840
Device Problems Device Emits Odor (1425); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The technical service engineer (tse) troubleshot this issue with the customer over the phone.The tse provide the compressor kit replacement that was requested by the customer.Customer will change the compressor kit and will call back if further assistance is required.Covidien was not authorized to evaluate the device.
 
Event Description
It was reported that the 840 ventilator had a noisy compressor and burning smell.The ventilator was not in use on a patient at the time the malfunction occurred.
 
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Brand Name
840 VENTILATOR
Type of Device
CONTINUOUS VENTILATOR
Manufacturer (Section D)
COVIDIEN
new mervue industrial park
michael collins road
galway
EI 
Manufacturer (Section G)
COVIDIEN
new mervue industrial park
michael collins road
galway
EI  
Manufacturer Contact
ray maroofian
2101 faraday ave.
carlsbad, CA 92008
7606035334
MDR Report Key6204334
MDR Text Key63276713
Report Number8020893-2016-03612
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number840
Device Catalogue Number4-840120DIUU-US
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2009
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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