MAUDE Adverse Event Report: MORTARA INSTRUMENT, INC SURVEYOR CENTRAL

Model Number SCSYS-EED-FBFAX

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

Patient Problem Torsades-de-Pointes (2107)

Event Date 12/30/2015

Event Type  Death  

Manufacturer Narrative

The system log files and audit trail were reviewed and identified the surveyor system functioned normally, and that alarms were active at the moment of the event.At 22:13:17 the ecg signal was interrupted and a "no ecg monitoring" alarm was generated.At 22:15:21 hospital personnel silenced the alarms for "no radio signal" and "no ecg monitoring".Patient was discharged (monitoring interrupted) by personnel at 23:05:13.The patient was found lying on the floor, and the body of the patient shielded the transmitter causing the ecg signal interruption.The printouts of the event were reviewed.The system did not detect all beats during the torsades de pointes because of the typical low slew rate of the waves and the heart rate measured by the program did not reach more than 130 bpm.Some beats were classified as ventricular and some were not because of the irregular time and shape of the detected beats.During the torsades de pointes event, the system classified 6 beats as ventricular and then the ecg signal was interrupted.According to the customer, the threshold for a ventricular tachycardia alarm was set at 10 beats, 120 bpm.The ecg printouts show the patient had a very prolonged qt-duration, which is a risk factor for torsades de pointes.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.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 a torsades de pointes (tdp) heart rhythm was not recognized by the system.The patient expired.

• Brand Name: SURVEYOR CENTRAL
• Type of Device: SURVEYOR CENTRAL
• Manufacturer (Section D): MORTARA INSTRUMENT, INC; 7865 north 86th street; milwaukee WI 53224
• Manufacturer Contact: tim field ; 7865 north 86th street; milwaukee, WI 53224 ; 4143541600
• MDR Report Key: 5460257
• MDR Text Key: 39010064
• Report Number: 2183461-2016-00001
• 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: Physician
• Type of Report: Initial
• Report Date: 02/25/2016

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-FBFAX
• Device Catalogue Number: SCSYS-EED-FBFAX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2009
• 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): Death