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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. ELECTROCARDIOGRAPH

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. ELECTROCARDIOGRAPH Back to Search Results
Device Problems Device Alarm System (1012); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2018
Event Type  Malfunction  
Event Description

Electrocardiogram machines related to the amplitude settings. Ours (ge) have a window that pops up and prompts the technician to change the gain in order to prevent high amplitude tracings from overlapping. This creates a scary scenario when the reader doesn't realize the gain has changed. As you know, the amplitude is buried on the side and bottom of the printouts.

 
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Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 w tower ave
milwaukee WI 53223
MDR Report Key9122949
MDR Text Key160173031
Report Number9122949
Device Sequence Number1
Product Code DPS
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 08/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2019
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2019
Event Location Hospital
Date Report TO Manufacturer09/26/2019
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

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