MAUDE Adverse Event Report: GE HEALTHCARE GE 5500 EKG MACHINE

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?.

• Brand Name: GE 5500 EKG MACHINE
• Type of Device: GE 5500 EKG MACHINE
• Manufacturer (Section D): GE HEALTHCARE
• MDR Report Key: 7533916
• MDR Text Key: 109070627
• Report Number: MW5077367
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/21/2018
• 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