MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIBRIDGE

Model Number	INTELLIBRIDGE EC40/80
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: serial number and udi has been requested; no information is provided or made available at time of report.E1: institution phone # (b)(6).E1: reporter phone # (b)(6).The remote service engineer (rse) advised the customer to check the standby parameter setting and to restart the device to resolve the issue.The device was operational after restarting the device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
It was reported that the intellibridge ec80 hub is not reporting ventilator alarms to the central station.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
After further review, this case was determined to be non-reportable with philips.There was no report of death or serious injury nor was there a report of any user or patient impact.The customer was reporting that the respirator alarms do not always go back to the central unit.The primary alarms are provided by the connected non philips device (i.E.Ventilator) and are provided independent of the intellibridge module/ monitor.The investigation may reveal that the alarm configuration may need to change at the module so that alarms are provided to match the external device alarm priority levels - note that the loss of communication between the module and the third party ventilator would not interrupt monitoring and alarm functions of the philips bedside monitor, and that the ventilator would still provide audible alarms as appropriate.Also note that interruption of data acquisition via the module would generate an inop message and alarm tone.The remote service engineer (rse) advised the customer to check the standby parameter setting and to restart the device.The rse also indicated that he suspects that the network cables the customer is using are not suitable (shielded whereas it should be unshielded) which could untimely interference and disconnections.It was advised that the network cables be replaces, changed from shielded to unshielded.The customer was advised to restart the device to resolve the issue.The device was operational after restarting the device and there has been no feedback from the customer since the replacement cables were ordered.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIBRIDGE
• Common Device Name: INTELLIBRIDGE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 22383875
• Report Number: 1218950-2025-000376
• Device Sequence Number: 15238346
• Product Code: MHX
• UDI-Device Identifier: 00884838090811
• UDI-Public: (01)00884838090811
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: Health Professional
• Device Model Number: INTELLIBRIDGE EC40/80
• Device Catalogue Number: 865056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/26/2025
• 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