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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MALLINCKRODT; CO2 DETECTOR
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COVIDIEN MALLINCKRODT; CO2 DETECTOR Back to Search Results
Model Number EASYCAP II
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2015
Event Type  malfunction  
Event Description
It was reported that during use, the product did not change color.There is no report of serious injury or death associated with this event.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Covidien reference number: (b)(4).A sample was received for evaluation.The product was open and the paper color was yellow.Unable to determine if the product failed out of box as there was no sealed sample sent to evaluate.The reported issue is not associated with a current trend.
 
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Brand Name
MALLINCKRODT
Type of Device
CO2 DETECTOR
Manufacturer (Section D)
COVIDIEN
blvd. insurgentes parcela #37
tijuana, bc 22570
MX  22570
Manufacturer (Section G)
COVIDIEN
blvd. insurgentes parcela #37
tijuana, bc
MX  
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key4698560
MDR Text Key5716275
Report Number2936999-2015-00337
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K894053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEASYCAP II
Device Catalogue NumberEASYCAP II
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/06/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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