MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number	865241
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an intellivue mx700 patient monitor indicating that there was a "speaker malfunction" error while using a bedside monitor and an x3 on a patient.The customer biomedical engineer (biomed) wanted to determine whether the issue originated from the mx700 bedside monitor or the x3.It was not known if the speaker was able to produce sound.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer biomedical engineer (biomed).The rse explained that to identify the faulty device, they would need to separate the two (mx700 and x3) devices and observe which one continues to display the error.However, the customer was unable to perform this test at the time due to the presence of a patient.Additional information was requested regarding the speaker producing sound.However, the biomed mentioned that they didn¿t have any speaker issue at that time and did not want to troubleshoot more.No further information was provided, regarding the sound.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not able to be confirmed at the time of the call with the biomed but could not be ruled out at the time of the event.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX700 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: 21686654
• Report Number: 9610816-2025-000199
• Device Sequence Number: 13081802
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2018
• 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