MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES PRUCKA 3.0 AMPLIFIER; ELECTROCARDIOGRAPH

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, the 3rd party non-abbott amplifier (prucka 3.0) would not pass the self-test or communicate, and the system color mapping was not working properly, resulting in delay of the procedure.When the navigation mode was changed from navx mode to voxel mode, it was reported that the non-abbott amplifier (prucka 3.0) orange led light blinked and did not turn to the green light.The non-abbott amplifier (prucka 3.0) was powered off and all the cables were disconnected from the front panel and then re-power on, then it went to the green light.The amplifier to ensite x display workstation communication error came up several times.It was then attempted to re-connect the lc cable with no resolution.The lc cable was then exchanged, resolving the issue.There was also a field frame generator communication error that came up.The non-abbott amplifier (prucka 3.0) was re-connected and rebooted several times and the issue resolved.The respiration button was attempted, but a patch impedance error came up.A right leg patch disconnected error message appeared, so the right leg patch was exchanged, resolving the issue.Geometry collection was then completed, however, there was an issue with the color mapping.It was attempted to reset metal distortion, re-collect respiration, re-validation, resume the study, collect voxel, and moving the catheter to voxel to a high-density zone without resolve.The procedure was then completed using a 3rd party system with no adverse patient consequences.The issues were alleged to be due to the non-abbott amplifier (prucka 3.0).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PRUCKA 3.0 AMPLIFIER
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
• MDR Report Key: 18193097
• MDR Text Key: 329065904
• Report Number: MW5148391
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Patient Sequence Number: 1