MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI-MEASUREMENT MODULE MMX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	INTELLIVUE MMX
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer who stated the spo2 probe was not detecting and displaying inaccurate oxygen saturation.The rse determined the spo2 sensor would need to be replaced.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 faulty spo2 sensor.The issue was resolved by the customer replacing the sensor.No follow-up was requested by the customer; no additional information was provided based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.If additional information is received, the complaint file will be reopened for further investigation.E1: reporting institution phone #: (b)(6).Reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on an intellivue mmx device indicating that the spo2 probe is not detecting and was displaying inaccurate oxygen saturation.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: INTELLIVUE MULTI-MEASUREMENT MODULE MMX
• 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 ; 70314632031
• MDR Report Key: 25365516
• Report Number: 9610816-2026-101077
• Device Sequence Number: 9847532
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: (01)00884838086760
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K181831
• 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): 06/02/2026

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 MMX
• Device Catalogue Number: 867036
• 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: 05/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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