MAUDE Adverse Event Report: WELCH ALLYN, INC. ITA CTRL TELEM 220 VAC 32S 24C S4; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number SCNODE-BEB-CMXXX

Device Problem No Audible Alarm (1019)

Patient Problems Arrhythmia (1721); No Patient Involvement (2645)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The surveyor central station system is intended for monitoring of physiological signs, including cardiac and vital signs, for multiple patients within a medical facility.The system can receive, display and store data from up to a maximum of 64 multi-parameter patient monitors, mobile monitors, and/or telemetry systems.Hillrom has requested the log files for the impacted device in order to determine if there was any malfunction or if the device functioned as intended.As the results of this log file analysis are pending, hillrom are submitting a report in the absence of clear information.A clinical assessment was performed which determined that based on the report of no patient injury, serious deterioration in the state of health, or death, this event is not reportable for any of these clinical conditions.No further information is available at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer reported that there was no alarm audio signal at the surveyor central when ventricular tachycardia occurred.There was no report of patient injury or death received.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Two initial mdrs were submitted to the fda on 31 dec 2020 (1316463-2020-00016 and 1316463-2020-00017).However, further investigation into this incident has revealed that there was only one incident which was reported twice to hillrom.Once by the customer and a second time by the hillrom service technician who attended the customer¿s facility for intervention.This was a communication error internally within hillrom and the investigation for both will focus on only this one incident.The customer reported that a patient monitored with an s4 telemetry suffered an arrhythmia.The patient had an implanted pacemaker / icd.It was also reported by the customer that the surveyor central did not alarm the event failing to warn the nurses with the sound.The surveyor central station system is intended for monitoring of physiological signs, including cardiac and vital signs, for multiple patients within a medical facility.The system can receive, display and store data from up to a maximum of 64 multi-parameter patient monitors, mobile monitors, and/or telemetry systems.The system can support patient monitoring and telemetry monitoring modes simultaneously.Patient monitors can be surveyor s12 or s19 patient monitoring systems.Ambulatory telemetry transmitter and mobile monitor sources can be surveyor s4 systems.In telemetry monitoring mode, the surveyor central station provides primary monitoring of patients including display of values and waveforms, alarm generation and management, data storage, patient management and report printing functionality.Patients are monitored through telemetry, when moving in a defined area, of a variable size depending on layout and thickness of walls.Logfile analysis was performed to establish how the veritas analysis program determined the arrhythmia classification and, if applicable, consequent alarms, using the recorded ecg as input.The event relative to the complaint started at 04:33:01.The icd (implanted cardiac device) fired at 04:33:30.The surveyor system gave a medium priority high heart rate alarm at 04:33:08 which turned off at 04:33:58, and a ventricular run message 04:33:10 (not visible because hidden by the heart rate alarm).Log files from the system did not show any anomalies in the processes that generate the visible and auditory alarm signals.It is likely that the heart rate alarm had already gone away when the patient called and that it was not noticed for this reason.The presence of an electronic pacemaker complicates the analysis for arrhythmias.It is for this reason that standards for arrhythmia monitors require manufacturers to include a warning in the user manual: keep pacemaker patients under close surveillance.In this case, the presence of the pacemaker has compromised the detection of ventricular tachycardia.However, the heart rate was correctly measured, and the appropriate alarm was given.It can be concluded that the system has functioned as designed and no anomalies were found.Clinical evaluation: no injury or death was reported with the event.The patient¿s arrhythmia was stopped by his icd, the patient called to notify the nurse and there were no further health issues after the event.It is noted that the caregivers cant say if they saw the alarm message blinking in the patient slot of the central display.However, an examination of the device notification logs found the event stored in the review alarm list.The surveyor central station system is intended for monitoring of physiological signs, including cardiac and vital signs, for multiple patients within a medical facility.The device ifu states maintain proper clinical assessment and close surveillance for patients with pacemakers during continuous ecg monitoring.It is unlikely that the device caused or contributed to the patients reported arrhythmia, but rather the event can be contributed to the patients underlying condition and need for his icd.No malfunction was identified.There was no report of serious injury or death.Based on the information above, this does not meet the definition of a reportable malfunction that could lead to serious injury or death if it were to recur.Hillrom does not consider this complaint reportable.

Event Description

The customer reported that there was no alarm audio signal at the surveyor central when ventricular tachycardia occurred.There was no report of patient injury or death received.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ITA CTRL TELEM 220 VAC 32S 24C S4
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 11100291
• MDR Text Key: 227881449
• Report Number: 1316463-2020-00016
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094325287
• UDI-Public: 732094325287
• Combination Product (y/n): N
• PMA/PMN Number: K131929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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: SCNODE-BEB-CMXXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1