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U.S. Department of Health and Human Services

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

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC ELECTROCARDIOGRAPH Back to Search Results
Device Problem Unable to Obtain Readings (1516)
Patient Problem Insufficient Information (4580)
Event Date 09/07/2020
Event Type  Injury  
Event Description

During renal replacement therapy, electrocardiogram (ekg) was ordered. When patient barcode was scanned with ekg machine, barcode did not read properly. Ekg was obtained under previous patient's medical record number saved in ekg machine.

 
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Brand NameMAC
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 west tower avenue
milwaukee WI 53223
MDR Report Key10726400
MDR Text Key212726741
Report Number10726400
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 RISK MANAGER
Type of Report Initial
Report Date 10/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/14/2020
Event Location Hospital
Date Report TO Manufacturer10/23/2020
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? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/23/2020 Patient Sequence Number: 1
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