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

Model Number	865115
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer onsite to evaluate the device in question.The rse indicated during a conversation with the customer that the device in question was sent immediately to the bench and a request for a repair to the device or replacement be sent was for acknowledged.The customer was provided a replacement device to resolve their issue.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Reporting address postal (b)(6).Reporting institution phone # (b)(6) reporting phone # (b)(6) reporting address postal (b)(6).
Event or Problem Description
Philips received a complaint on the intellibridge ec10 module system indicating an unspecific alarm issue.It is unknown if the device was not in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.

• 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: 20819319
• Report Number: 9610816-2024-000916
• Device Sequence Number: 8928669
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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
• Device Model Number: 865115
• Device Catalogue Number: 865115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2022
• 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