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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL INFORMATION TECHNOLOGIES, INC. MAC 5500 HD ELECTROCARDIOGRAPH

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GE MEDICAL INFORMATION TECHNOLOGIES, INC. MAC 5500 HD ELECTROCARDIOGRAPH Back to Search Results
Model Number MAC5500
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Injury (2348)
Event Date 02/28/2015
Event Type  Malfunction  
Event Description

A pt's name was chosen in error from a list of ekgs needing to be completed after the 'correct' patient's name had been hand entered and the machine switched off and back on again (manually). Subsequently, the ekg with the incorrect pt's name on it uploaded to the actual pt's medical record although this ekg was not from the actual pt herself. This ekg was completed in the emergency department after the actual pt was already up on ccmu (critical care medical unit). The actual pt went up to ccmu at 2100 and this ekg was completed on patient in the emergency dept at 2120. Based on an (the) ekg uploaded to the actual patient's chart, the actual patient underwent cardiac cath. The ekg had the actual patient's name on it. The ekg that the catheterization was based on was found to be that of the incorrect patient chosen in error from the list of ekg's needing to be completed). Manufacturer is aware of the issue and was able to duplicate the problem at the company. No permanent fix at this time. Risk for harm still exists. This resulted in an adverse event of the wrong procedure that was performed on the wrong patient. Manufacturer cannot revert back to an older software version.

 
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Brand NameMAC 5500 HD
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL INFORMATION TECHNOLOGIES, INC.
8200 w tower ave
milwaukee WI 53223
MDR Report Key4722051
MDR Text Key15320168
Report Number4722051
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 04/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2015
Is This A Product Problem Report? Yes
Device Operator INVALID DATA
Device MODEL NumberMAC5500
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2015
Event Location Hospital
Date Report TO Manufacturer04/23/2015
Is this a Reprocessed and Reused Single-Use Device? No

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