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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH NEONATAL PREWIRED ELECTRODE 0.9 INCH

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CARDINAL HEALTH NEONATAL PREWIRED ELECTRODE 0.9 INCH Back to Search Results
Lot Number 161227
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2017
Event Type  malfunction  
Event Description
Monitoring neonatal electrode wire placed on neonate to monitor heart rate was found to be disconnected from circular electrode pad.Electrode on patient less than 2 hours.Electrode replaced with new electrode and the same thing occurred with 3 different electrodes in a neonate that was not moving excessively.Electrodes replaced x 4.Is the product compounded: no.Is the product over-the-counter: no.
 
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Brand Name
NEONATAL PREWIRED ELECTRODE 0.9 INCH
Type of Device
NEONATAL PREWIRED ELECTRODE
Manufacturer (Section D)
CARDINAL HEALTH
dublin OH 43017
MDR Report Key6618394
MDR Text Key77002016
Report NumberMW5070200
Device Sequence Number3
Product Code IKD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/02/2017
4 Devices were Involved in the Event: 1   2   3   4  
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 Expiration Date12/30/2019
Device Lot Number161227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/02/2017
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 Age4 YR
Patient Weight4
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