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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY GE; CABLE, ELECTRODE
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GE HEALTHCARE FINLAND OY GE; CABLE, ELECTRODE Back to Search Results
Model Number ECG LEADWIRE SET, 5-LEAD V2-6, SNAP, AHA, 130 CM/ 51 IN
Device Problem Misassembled (1398)
Patient Problem Insufficient Information (4580)
Event Date 01/04/2021
Event Type  malfunction  
Event Description
Electrocardiograms (ekg) performed by another nurse on a patient in emergency department room were noted to be markedly different than her prior.The doctor requested additional ekg done on an ekg cart, which then were similar to her prior ekg's on record.Monitor and cables were inspected by this nurse and noted that the lead cables v2-v6 were all plugged into the incorrect places and were clipped into place that way by a brown holder clip.Cable cord was replaced with a cable cord that was correctly wired.Unable to unplug the leads in order to place in correct places.Removed from service immediately and tagged for biomed inspection/repair.
 
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Brand Name
GE
Type of Device
CABLE, ELECTRODE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
3000 n. grandview blvd.
waukesha WI 53188
MDR Report Key11123060
MDR Text Key225332833
Report Number11123060
Device Sequence Number1
Product Code IKD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/05/2021,01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberECG LEADWIRE SET, 5-LEAD V2-6, SNAP, AHA, 130 CM/ 51 IN
Device Catalogue Number416467-001
Device Lot Number025018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/05/2021
Event Location Hospital
Date Report to Manufacturer01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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