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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE GE 5500 EKG MACHINE

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GE HEALTHCARE GE 5500 EKG MACHINE Back to Search Results
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

The patient went up to the icu, where the pa noted the low voltage setting. The cardiac catheterization team was activated, and they found multi-vessel disease. No intervention was performed and the patient was transferred to (b)(6) for evaluation for urgent cabg. As of this moment, i think that is still being done (no surgery yet). Our goal is door-to-balloon of 90 minutes. There was no balloon here, but i think the cath happened at around 180 minutes. There was no intervention, and so i would say there was no resulting harm from the event. The main issue is the ability for a user to change the size of voltage. This can lead to incorrect reading of an ekg. The "little box" is not enough to warn for low voltage settings, and i also wonder if it can be locked or if the warning can be more prominent?.

 
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Brand NameGE 5500 EKG MACHINE
Type of DeviceGE 5500 EKG MACHINE
Manufacturer (Section D)
GE HEALTHCARE
MDR Report Key7533916
MDR Text Key109070627
Report NumberMW5077367
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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