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

Model Number 2.410308

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Discomfort (2330)

Event Date 09/21/2020

Event Type  malfunction  

Event 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
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): SCHILLER AG; 10903 nw 33rd st; doral FL 33172
• MDR Report Key: 10634651
• MDR Text Key: 209995188
• Report Number: 10634651
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 07613365000344
• UDI-Public: (01)07613365000344
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 2.410308
• Device Catalogue Number: 2.410308
• Device Lot Number: 2819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Weight: 147