MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX500 PATIENT MONITOR

Model Number	INTELLIVUE PATIENT MONITOR MX500
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was presented with a speaker malfunction error message.No sound was coming from the device.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel.The field service engineer (fse) confirmed the reported issue and tested the alleged device.The results of the analysis were that the device speaker was found defective and needed replacement.Based on the results of the analysis, it was determined that the product has malfunctioned and the cause of the reported problem was a defective speaker assembly.The issue was resolved by replacing the defective part and the product is confirmed to be operation per its specification.E1: reporting institution phone#: (b)(6).E1: reporter phone #: (b)(6).

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX500 PATIENT MONITOR
• 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: 25459879
• Report Number: 9610816-2026-101123
• Device Sequence Number: 10450401
• Product Code: MHX
• UDI-Device Identifier: 00884838038776
• UDI-Public: (01)00884838038776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131872
• 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): 06/10/2026

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: INTELLIVUE PATIENT MONITOR MX500
• Device Catalogue Number: 866064
• 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: 05/15/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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