MAUDE Adverse Event Report: ASCOM SWEDEN AB TELLIGENCE BRIDGE SOFTWARE; NURSE CALL SYSTEM

Model Number	NGTELL73-S
Medical Device Problem Codes	Device Alarm System (1012); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2025
Type of Reportable Event	Death
Event or Problem Description
At approximately 01:20 eest on (b)(6) 2025, a patient was found lifeless by clinical staff at a customer site (hospital) in finland in room 38 on ward 4b.Clinical staff immediately started cpr, and attempted to initiate a "cpr alarm" by pressing the emergency button on the ascom telligence nurse call 'nubm3-he bedside module' device mounted on the wall, but the alert did not register in the telligence nurse call system.The clinical staff discovered that the telligence nurse call system was not registering the nurse call events from the telligence nurse call devices within room 38 on ward 4b.The patient subsequently was reported deceased after resuscitation attempts were unsuccessful.The problem reported was confirmed to be due to telligence nurse call room devices in room 38 being "offline" starting from 13:16 eest on (b)(6) 2025.The telligence nurse call system worked as intended to annunciate the errors for the offline room devices on the staff console in ward 4b, but clinical staff did not respond to such alert and room devices remained in an offline state.The issue was reported to ascom after the event and a field engineer restored functionality on (b)(6) 2025 by disconnecting and reconnecting power to the nudl4s-h dome light for room 38, which all the offline room devices were connected to.The reason for the room devices going "offline" is still undetermined and under investigation.There is currently no evidence to suspect other devices are impacted by this issue and any risk is considered sufficiently mitigated via the controls designed within the system which ensure end users are alerted to any device failures as soon as they occur.
Additional Manufacturer Narrative
The system which is distributed in finland is the telligence bridge software 7.3.3 (udi: (b)(4) which was not released on the us market.The telligence 7.4 (udi: (b)(4) is the first version of telligence 7.X system introduced in the us market, but which is similar to the telligence bridge software v7.3.3.Additionally, the room devices which were reported to be offline during this event are the eu variants of these devices, which feature some differences but are similar to the us variants.While this event involves both software and hardware, the main system software (i.E.Telligence bridge software) has been identified as the suspected product as investigation of the hardware has not identified any specific fault and the root cause of the issue has yet to be determined.There is not currently considered to be any need for corrective action on the us market in response to this event.

• Brand Name: TELLIGENCE BRIDGE SOFTWARE
• Common Device Name: NURSE CALL SYSTEM
• Manufacturer (Section D): ASCOM SWEDEN AB; grimbodalen 2; vastra gotaland, gothenburg SE-41 749; SW SE-41749
• Manufacturer Contact: sarah jolleys ; 300 perimeter park dr; morrisville, NC 27560 ; 9198155004
• MDR Report Key: 23429839
• Report Number: 3008952681-2025-00001
• Device Sequence Number: 8179166
• Product Code: IQA
• UDI-Device Identifier: 17350088671426
• UDI-Public: (01)17350088671426(10)7.3.3(11)240122
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NGTELL73-S
• Device Catalogue Number: SW000795/070303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown