MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIBRIDGE EC10 MODULE

Model Number	INTELLIBRIDGE EC10 MODULE
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.E1: reporting institution phone#: (b)(6).
Event or Problem Description
It was reported that the customer is using intellibridge modules for data transmission.Since he recently purchased capsule e devices to digitize the ventilation data he is no longer receiving alarms on the control center via the intellibridge modules.Patient involvement is unknown.There was no report of patient or user harm.
Additional Manufacturer Narrative
The remote support engineer (rse) reached out to the asp who confirmed the customer has consulted with his retailer and the problem was resolved.No further work was performed by philips.Further analysis was performed by product support engineering (pse) who advised the customer should use a y-cable.The y-cable would allow sending data to both capsule and ec10 at the same time from the hamilton c3 vent.The pse stated further that connecting a third-party device via intellibridge is a point-to-point connection.If the customer uses a y-cable, the connection no longer meets specifications.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem was a user issue.Based on the information available and results of additional analysis, no further action is necessary at this time.

• Brand Name: INTELLIBRIDGE EC10 MODULE
• Common Device Name: INTELLIBRIDGE EC10 MODULE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 23166219
• Report Number: 9610816-2025-000887
• Device Sequence Number: 8882041
• Product Code: MHX
• UDI-Device Identifier: 00884838015951
• UDI-Public: (01)00884838015951
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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 EC10 MODULE
• Device Catalogue Number: 865115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2021
• 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