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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL ACCESSORIES AND CABLES GE HEALTHCARE EKG LEADWIRES; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
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MEDICAL ACCESSORIES AND CABLES GE HEALTHCARE EKG LEADWIRES; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) Back to Search Results
Model Number GE CA14 UNIVERSAL COMPATIBLE CABLE
Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inadequacy of Device Shape and/or Size (1583)
Patient Problem Insufficient Information (4580)
Event Date 04/05/2021
Event Type  malfunction  
Event Description
Multiple complaints for cardiology department that ekg are not readable or have different output.Emergency department notified clinical engineering.During the clinical engineering investigation, we found out that the leads that were used are from a third party (medical associates and cables).We found out that the diameter of the leads is too small compared to the diameter of the ge cable.The cable was too loose causing intermittent or wrong ekg outputs.
 
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Brand Name
GE HEALTHCARE EKG LEADWIRES
Type of Device
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Manufacturer (Section D)
MEDICAL ACCESSORIES AND CABLES
4669 southwet fwy suite #595
houston TX 77027
MDR Report Key11626822
MDR Text Key244193715
Report Number11626822
Device Sequence Number1
Product Code DSA
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 04/06/2021,04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGE CA14 UNIVERSAL COMPATIBLE CABLE
Device Catalogue NumberMQMB10-AD
Device Lot Number1200317076
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/06/2021
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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