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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES EKG MACHINE; ELECTROCARDIOGRAPH
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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES EKG MACHINE; ELECTROCARDIOGRAPH Back to Search Results
Model Number MACVU 360
Device Problems Break (1069); Thermal Decomposition of Device (1071); Device Emits Odor (1425); Improper or Incorrect Procedure or Method (2017); Connection Problem (2900); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2023
Event Type  malfunction  
Event Description
Cardiac surgery patient needed an ekg completed.Upon connecting the patient to the machine, there was an error code stating it was not connected.After troubleshooting, nursing staff smelt something burning and found the ekg cables were hot to touch.Patient immediately disconnected from machine and ekg removed from use.The cable connecting the acquisition module to the ekg machine was found to be visibly burnt/charred next to the connector at the acquisition module end.It appeared that the acquisition module had been inserted incorrectly into the holder, partially breaking the cable to ekg machine.The correct orientation of the acquisition module in the holder is when the picture on the module is upside down, which is not intuitive.
 
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Brand Name
EKG MACHINE
Type of Device
ELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MDR Report Key16743384
MDR Text Key313405768
Report NumberMW5116631
Device Sequence Number1
Product Code DPS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/11/2023
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 NumberMACVU 360
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/13/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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