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U.S. Department of Health and Human Services

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

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GE MEDICAL INFORMATION TECHNOLOGIES, INC. ELECTROCARDIOGRAPH Back to Search Results
Device Problems Cable, Electrical (423); Monitor (886); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2016
Event Type  Malfunction  
Event Description

The ekg monitor/cables were not working. The patient was with no ekg for over an hour. After switching between wires, cables, and monitors, we concluded that the ekg wires, the ekg cable and the monitor itself all malfunctioned. All three had to be changed together to get a functional ekg. No patient harm.

 
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Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL INFORMATION TECHNOLOGIES, INC.
465 pan american drive suite 11
el paso TX 79907
MDR Report Key5784850
MDR Text Key49246609
Report Number5784850
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2016
Is This A Product Problem Report? Yes
Device Operator
OTHER Device ID Number401575175
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/19/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2016
Event Location Hospital
Date Report TO Manufacturer06/10/2016
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?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/12/2016 Patient Sequence Number: 1
Treatment
NO
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