MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue MX450 Patient Monitor; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue Patient Monitor MX450
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a intellivue mx450 patient monitor indicating that the monitor displays a speaker malfunction error message.Additional information received from the customer confirmed that the device produced no audible sound.The device was in use on a patient at the time of event, no adverse event was reported.
Additional Manufacturer Narrative
E1 reporter phone #: (b)(6).Analysis was performed by remote service personnel which included troubleshooting.The reported issue was successfully replicated, and troubleshooting confirmed a speaker malfunction.Cross-check testing was conducted to support the diagnostic findings and conclusions.Based on the investigation, the reported problem was attributed to a speaker malfunction.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a speaker malfunction within the loudspeaker assembly.The customer was informed that the part needs to be replaced.A loudspeaker assembly ((b)(4), iv2-flex mechasy loudspeaker assembly), was ordered and shipped to the customer.

• Brand Name: IntelliVue MX450 Patient Monitor
• Common Device Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
• 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 ; +49(703)14632031
• MDR Report Key: 50852453
• Report Number: 9610816-2026-101973
• Device Sequence Number: 10053506
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: (01)00884838038769
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130849
• 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): 09/22/2026

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 MX450
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2019
• 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