MAUDE Adverse Event Report: MORTARA INSTRUMENT ENG. 110V 32SL 608MHZ W/MONITORS; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	SCNODE-BAA-CNXFX
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the device log files by a (b)(4) technician to determine the root cause of the issue is still pending.The customer has confirmed that there was no patient injury, however as both central monitoring stations were loosing connection intermittently, this has been determined to be a reportable malfunction by (b)(4), until further investigation results are made available.No further information is available on the device at this time.The (b)(4) technician will be going on site to investigate the reported issue thoroughly.(b)(4) will submit a final report with investigation conclusion on this incident.
Event or Problem Description
The customer reported that the network connection from the computers at the surveyor station to the switch in the server room is going out intermittently.It has happened for both 16 channel systems at different times.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional 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.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 patient monitoring mode, the patient monitors provide primary monitoring functionality while the surveyor central station system provides continuous secondary monitoring of patients including alarm reception and management, display and storage of parameters and waveforms including full-disclosure, automatic and on-demand generation of various printed reports using a network-attached printer.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.In order to guarantee a proper signal transmission in each different situation, an antenna network can be installed according to customer needs.The data and analysis provided by the surveyor central station is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various conditions.The hrc technician went onsite to inspect the reported incident and inspect the network connection.The technician checked the switch and connectivity from all nodes of the system and found not network connectivity issues.Additionally the customer stated that the issue had not occurred since the reported event between one and two months back.The hrc technician investigated the device thoroughly and could not replicate the reported issue.No malfunction.There was no serious incident reported.Therefore, hillrom does not consider this complaint reportable.The system is functioning as designed.Based on this information, no further action is required.
Event or Problem Description
The customer reported that the network connection from the computers at the surveyor station to the switch in the server room is going out intermittently.It has happened for both 16 channel systems at different times.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(6).

• Brand Name: ENG. 110V 32SL 608MHZ W/MONITORS
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: sarah oreilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12874495
• Report Number: 2183461-2021-00012
• Device Sequence Number: 4638513
• Product Code: MHX
• UDI-Device Identifier: 00732094307900
• UDI-Public: 732094307900
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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 Model Number: SCNODE-BAA-CNXFX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown