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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 Premature Discharge of Battery (1057)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The customer reported to have replaced the batteries. Covidien was not authorized to repair the device.
 
Event Description
It was reported that, the batteries in an 840 ventilator were completely depleted. Although requested, information pertaining to the use of the device at the time of the reported event and patient outcome (if applicable) has not been provided.
 
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Brand Name840 VENTILATOR
Type of DeviceCONTINUOUS 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 Key6177292
MDR Text Key62707284
Report Number8020893-2016-03481
Device Sequence Number1
Product Code CBK
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 Health Care Professional
Type of Report Initial
Report Date 11/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number840
Device Catalogue Number4-840220DIUA-EN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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