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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 Problem Device Emits Odor (1425)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The service engineer (se) evaluated the ventilator and was unable to duplicate the customer reported malfunction.The unit was functioning as intended.The ventilator passed all testing and operates within the manufacturing specifications.
 
Event Description
It was reported that during patient use, a ventilator heater was reported to have a smoking smell.The patient was transferred to another ventilator without harm.
 
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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
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key5320633
MDR Text Key34179634
Report Number8020893-2015-01827
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 12/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number840
Device Catalogue Number840
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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