MAUDE Adverse Event Report: SCHILLER AG SCHILLER ECG WIRE SET; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	2.410308
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: merge leads that are used to monitor electrocardiogram for procedure were placed on patient (pt).Pt arrived to the interventional lab room in the morning.There were no arrhythmias or artifact noted at this time prior to case start.Once time out was completed, and lidocaine was transdermally given in the right radial territory the rhythm suddenly changed to what appeared to be monomorphic ventricular tachycardia (there was no indication that it was artifact due to no delay prior to change of rhythm and the rhythm remained in this monomorphic state).Doctor was notified and there had been approximately 5-6 screens of this ventricular tachycardia appearing rhythm.Doctor initiated cpr then registered technologist of radiography in room took over cpr.Nurse (rn) applied defib pads while another rn turned on defib equip to prepare for shock if needed.It was noted pt was awake but pt had received some sedation medications.The rhythm continued and to prevent pt from passing out if the rhythm was true pt was placed on defib equipment.An 'all available help was called' and staff were notified that a potential code could be occurring.Prior to charging the defib the room completed a rhythm check and cpr was paused.The defib monitor it showed pt was in sinus tachycardia.Merge screen showed that pt.Was still in ventricular tachycardia like rhythm.Pt reported slight discomfort.Cables were changed out.No harm to pt, pt remained hemodynamically stable.Doctor explained to pt what had occurred and pt verbally stated understanding.Procedure was able to be completed and there were no issues noted.Pt verbalized some discomfort from compressions - pt was medicated for pain.Leads were changed in room to old set of cables.

• Brand Name: SCHILLER ECG WIRE SET
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): SCHILLER AG; 10903 nw 33rd st; doral FL 33172
• MDR Report Key: 10634651
• Report Number: 10634651
• Device Sequence Number: 19127255
• Product Code: DSA
• UDI-Device Identifier: 07613365000344
• UDI-Public: (01)07613365000344
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2020
• Report Date (Section F): 09/24/2020

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
• Operator of Device: No Information
• Device Model Number: 2.410308
• Device Catalogue Number: 2.410308
• Device Lot Number: 2819
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 147
• Date Report Sent to FDA: 09/24/2020