MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC SURVEYOR CENTRAL

Model Number SCSYS-EED-RBEAX

Device Problems Device Alarm System (1012); Use of Incorrect Control/Treatment Settings (1126); False Positive Result (1227)

Patient Problem Ventricular Tachycardia (2132)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

System log files were reviewed.Event involved a patient with an implanted defibrillator and paced with an atrial pacemaker at a fixed rate of 85 bpm.The ventricular tachycardia limits were set at 8 beats, 130 bpm.High heart rate limit was set at 150 bpm.Over the course of a 4 day period, 5 monomorphic ventricular tachycardia's (mvt) occurred, all of which were terminated by a discharge of the patient's implanted defibrillator.According to the arrhythmia analysis review, the surveyor central generated a ventricular tachycardia alarm for the 4 mvts preceding the event in question.During the 5th mvt (event in question) a "high heart rate" alarm was generated but not a ventricular tachycardia alarm.The log files show a "lead fail" alarm 7 minutes before the event caused by the v3 lead becoming detached.The electrode was re-attached 3 minutes after the event in question and presumably was not attached during the event.For the 4 mvts preceding the event in question, the surveyor central labeled most beats as "ventricular", resulting in a ventricular tachycardia alarm.For the 5th mvt, the threshold of 8 consecutive ventricular labeled beats was not reached before the first defibrillation shock 6 seconds after the beginning of ventricular tachycardia.The threshold was not reached during the 6 second period between the first and second shock either, because the ecg signal was distorted due to the foregoing shock.The second shock ended the tachycardia.The surveyor central software program uses all available leads for qrs duration measurements.With the absence of lead v3, the qrs duration of several beats during the event were measured as significantly shorter than the "normal" beat, and therefore were not labeled as "ventricular".In the previous 4 mvts, all leads were attached and 8 consecutive beats were labeled as "ventricular" before the patient's implanted defibrillator discharged, resulting in a ventricular tachycardia alarm.For the event in question, the absence of lead v3 caused fewer beats to be labeled as "ventricular" and the alarm threshold of 8 consecutive beats was not reached before the defibrillator discharged.The investigation indicates that the system was operating normally and within performance specifications.The information reviewed did not indicate there was any system malfunction that may have contributed to this incident.However, the patient's implantable defibrillator did discharge during the event and intervened to presumably prevent permanent impairment of a body function.The surveyor central was, or may have been, a factor in the event as a result of user error when the user did not reattach lead v3.It is also advisable to calibrate rate alarm threshold settings to the specific patient.Given the fixed heart rate from the atrial pacemaker in this patient, the high heart rate threshold could have been set at a much lower level than 150 bpm.This would have generated a high priority "extreme tachycardia" alarm in this particular event.Within the warning section of the user manual, the operator is instructed to check various alarm settings after each patient admission to ensure whether the chosen alarm limits are appropriate for the individual patient.It is good clinical practice to tighten the limits for ventricular tachycardia and heart rate and have the patient more closely watched when exhibiting certain risk factors.The investigation is complete and no further action will be taken.

Event Description

The customer reported the surveyor central system failed to detect a ventricular tachycardia.The patient's implantable defibrillator discharged during the event.

• Brand Name: SURVEYOR CENTRAL
• Type of Device: SURVEYOR CENTRAL
• Manufacturer (Section D): MORTARA INSTRUMENT, INC; 7865 north 86th street; milwaukee WI 53224
• Manufacturer (Section G): MORTARA INSTRUMENT, INC; 7865 noth 86th street; milwaukee WI 53224
• Manufacturer Contact: tim field ; 7865 north 86th street; milwaukee, WI 53224 ; 4143541600
• MDR Report Key: 5461759
• MDR Text Key: 39077948
• Report Number: 2183461-2016-00002
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCSYS-EED-RBEAX
• Device Catalogue Number: SCSYS-EED-RBEAX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention