MAUDE Adverse Event Report: MORTARA INSTRUMENT GERMAN 220V 8 SL 8S4; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	SCNODE-ADB-AKBXX
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer alleged the surveyor central network lost connection with the monitoring system.There is no allegation of injury or death.The hillrom service technician replaced the installed router within 3-4 hours.The surveyor central is working again.Hillrom is investigating this issue, and will report back with findings with a final report.
Event or Problem Description
Hillrom received a report from the customer that the surveyor central network lost connection with the monitoring system.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Event or Problem Description
Hillrom received a report from the customer that the surveyor central network lost connection with the monitoring system.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint#: (b)(4).
Additional Manufacturer Narrative
The customer alleged the surveyor central network lost connection with the monitoring system.Hillrom technicians replaced the hillrom watchguard t35.Part# is 749320, watchguard t35.Patient being monitored with the surveyor s4 system were switched over to a stand alone patient monitoring system.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.Hillrom technician investigated the surveyor central and confirmed the surveyor central provided an error message "network disconnected" in the lower left side of the display to alert the user the transmitter has lost connection to the monitoring node.Hillrom technician also confirmed the watchguard t35 was consistently rebooting in a loop and due to the hardware malfunction further analysis is not possible.There were no allegations of alarm deficiencies on any device reported.The affected watchguard was replaced by the hillrom technician.The network issue has now been resolved and the device is working as intended.

• Brand Name: GERMAN 220V 8 SL 8S4
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• MDR Report Key: 10454270
• Report Number: 2183461-2020-00003
• Device Sequence Number: 3218635
• Product Code: MHX
• UDI-Device Identifier: 00732094262810
• UDI-Public: 732094262810
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: SCNODE-ADB-AKBXX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1