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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES HEMODYNAMIC MONITORING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES HEMODYNAMIC MONITORING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 68721
Device Problem Defective Device (2588)
Patient Problems Asystole (4442); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/13/2021
Event Type  malfunction  
Event Description
Cardio lab shut down during a procedure due to the ablation window being manipulated. This is a known issue with the system. Unable to visualize ekg and intracardiac tracings. Therefore, unable to do emergency pace. Biomed called. Soft re-boot and system eventually came back on but without ablation recording. Also, the mouse was floating and it was very difficult to hover over the necessary channels needed to turn red for pacing capabilities. During reboot, patient had vagal response and went asystolic. External defibrillator pads used for pacing, no capture noted. Self-limiting and rhythm returned without further complications.
 
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Brand NameHEMODYNAMIC MONITORING SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower avenue
milwaukee WI 53223
MDR Report Key12040292
MDR Text Key257437276
Report Number12040292
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number68721
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2021
Event Location Hospital
Date Report to Manufacturer06/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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