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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
Model Number VU360
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2020
Event Type  Malfunction  
Event Description

The new ekg machines do not have a hard stop requiring staff to enter a patient identifier. The urgency to perform the ekg allowed the caregiver to by-pass the field to enter in patient data. The test was run but the report could not be reliably linked to the patient because no patient information was entered prior to running the ekg.

 
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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 Key10009045
MDR Text Key189329634
Report Number10009045
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 03/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVU360
Device Catalogue Number2030360-001
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/02/2020
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer04/29/2020
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? No
Type of Device Usage

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