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

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.

• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 9122949
• MDR Text Key: 160173031
• Report Number: 9122949
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA