MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX850

Model Number	INTELLIVUE PATIENT MONITOR MX850
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporter institution phone number:(b)(6).E1: reporter phone number: (b)(6).Reporting address line (b)(6).A philips remote service engineer (rse) interviewed the customer who confirmed the speaker was not functioning.A good faith effort (gfe) response indicated there was no sound at the time of the event.The gfe response also mentioned the customer was provided a quote for a replacement speaker.After the quote was accepted by the customer, philips delivered the speaker assembly to resolve the issue.Based on the information available, the cause of the reported problem was confirmed to be a speaker assembly.The reported problem was confirmed.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.
Event or Problem Description
It was reported there was a speaker malfunction error alarm.It was confirmed audio was not present at the time of the event.The device was in use on a patient at the time of the event, there was no adverse event reported.

• Brand Name: INTELLIVUE PATIENT MONITOR MX850
• Common Device Name: INTELLIVUE PATIENT MONITOR MX850
• 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: 23319582
• Report Number: 9610816-2025-000962
• Device Sequence Number: 4989366
• Product Code: MHX
• UDI-Device Identifier: 00884838070790
• UDI-Public: (01)00884838070790
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210906
• 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): 10/17/2025

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 MX850
• Device Catalogue Number: 866470
• 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: 09/23/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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