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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KENDALL 855; ELECTRODE, ELECTROCARDIOGRAPH
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COVIDIEN KENDALL 855; ELECTRODE, ELECTROCARDIOGRAPH Back to Search Results
Catalog Number 22855
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Burn(s) (1757)
Event Date 10/04/2016
Event Type  malfunction  
Event Description
Cardiac monitoring of critically ill children in the hospital environment provide a continuous monitoring and notification of cardiac arrhythmias.The disposable foam pads w/ gel insert are placed on 4 areas of the child's body: both on the right and left anterior chest just below the clavicle and both the right and left lateral abdomen at the level of the umbilicus.Although disposable electrodes may stay on the patient for two days, most electrodes are removed/ exchanged out for a new electrode on a daily basis with bathing routines.Of concern is the occasional report of a peripheral tissue burn which occurs under the snap area of the gel pad.An occasional blister has been reported.Product use over the two year period of reporting has been the kendall 133 foam electrode, the kendall 855 foam electrode and the kendall 935 foam electrodes.
 
Event Description
Cardiac monitoring of critically ill children in the hospital environment provide a continuous monitoring and notification of cardiac arrhythmias.The disposable foam pads w/ gel insert are placed on 4 areas of the child's body: both on the right and left anterior chest just below the clavicle and both the right and left lateral abdomen at the level of the umbilicus.Although disposable electrodes may stay on the patient for two days, most electrodes are removed/ exchanged out for a new electrode on a daily basis with bathing routines.Of concern is the occasional report of a peripheral tissue burn which occurs under the snap area of the gel pad.An occasional blister has been reported.Product use over the two year period of reporting has been the kendall 133 foam electrode, the kendall 855 foam electrode and the kendall 935 foam electrodes.
 
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Brand Name
KENDALL 855
Type of Device
ELECTRODE, ELECTROCARDIOGRAPH
Manufacturer (Section D)
COVIDIEN
two ludlow park dr.
chicopee MA 01022
MDR Report Key6105509
MDR Text Key60010641
Report Number6105509
Device Sequence Number1
Product Code DRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/04/2016,10/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/01/2018
Device Catalogue Number22855
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/04/2016
Event Location Hospital
Date Report to Manufacturer10/04/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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