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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL / COVIDIEN KENDALL DISPOSABLE LEAD SET; CABLE, ELECTRODE

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CARDINAL / COVIDIEN KENDALL DISPOSABLE LEAD SET; CABLE, ELECTRODE Back to Search Results
Model Number 33136T
Device Problem Defective Device (2588)
Patient Problem Complete Heart Block (2627)
Event Date 07/30/2017
Event Type  malfunction  
Event Description
The disposable leads from kendall on a pt had a defect and it was showing a posterior hemi block, ekg was performed showing sinus rhythm with first degree block as per previous ekg done in er.Leads were changed and no harm was caused.Five lead dual connect disposable lead set.Date of use (b)(6) 2017.Diagnosis or reason for use: elevated hr 140 range.
 
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Brand Name
KENDALL DISPOSABLE LEAD SET
Type of Device
CABLE, ELECTRODE
Manufacturer (Section D)
CARDINAL / COVIDIEN
15 hampshire st.
mansfield MA 02048
MDR Report Key6794088
MDR Text Key82821489
Report NumberMW5071569
Device Sequence Number1
Product Code IKD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number33136T
Device Catalogue Number33136T
Device Lot Number289267
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/07/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/14/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age91 YR
Patient Weight66
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