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	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the intellibridge ec40/80 indicating there was no more transmission of alarms from the fan to the monitor.The device was not in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
E1: reporting institution phone # (b)(6).E1: reporter phone # a philips field service engineer (fse) evaluated the device and confirmed there was no issue with the ec40.The issue with the ec40 was determined to originate from the customers fan model v500, as replacing all other components failed to resolve the problem until the customer set up a different v500 fan, which worked correctly.The device was confirmed to be operating per specifications, and the failure was identified with the non-philips device.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: 22993498
• Report Number: 1218950-2025-000518
• Device Sequence Number: 15661786
• 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
• Report Date (Section B): 09/08/2025

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): Initial
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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