MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue MX550 Patient Monitor; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue Patient Monitor MX550
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was managed as a nemo (no engineer material only) remote service event.Analysis was performed by a philips remote service engineer (rse) in consultation with the customer, during which the speaker was identified as the likely cause of the malfunction.As this was a remote service case, no philips engineer attended the site and the replaced component was not returned to philips, therefore further physical examination was not possible.The customer assumed responsibility to replace the speaker to resolve the issue.Section e: reporting institution phone #: (b)(6).
Event or Problem Description
Philips received a complaint on the intellivue mx550 patient monitor indicating that the speaker was malfunctioning, and there was no audible sound.The device was not in use on a patient at the time of the event, so there was no patient involvement.

• Brand Name: IntelliVue MX550 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: 50682044
• Report Number: 9610816-2026-101843
• Device Sequence Number: 14772105
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: (01)00884838038783
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/09/2026

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: Other
• Device Model Number: IntelliVue Patient Monitor MX550
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2017
• 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