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	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that the spo2 its only showing the line (wave) and not the numeric value of the spo2 measurement.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) contacted the customer biomed.The biomed stated that mmx device to measure patients' spo2 vital, is not displaying a numerical value.The biomed explained that he tried testing the mmx device on himself with the same cabling used by the staff with an mx450 monitor, tried testing the mmx using his simulator and tried using different cabling, all scenarios resulted in the device generating an spo2 waveform but no numeric.The rse asked the biomed if the monitor gave an inop alarm message and the response stated no inop alarm was given.The rse suspected a problem with the device's spo2 parameter board and/or spo2 adapter board but wanted to consult a philips remote application specialist (ras).The ras asked if the spo2 numeric label was seen and asked if a ? mark was displayed where the numeric should be.It was concluded that the spo2 parameter board and spo2 adapter board should be replaced.The biomed was provided the parts identification for the replacement parts and an onsite service request was submitted.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 board & spo2 adapter board.A philips field service engineer (fse) visited the customer site to perform repairs.The device was operational after repairs were completed.B3: date of event: update to correct reported event date.

• 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: 25186236
• Report Number: 9610816-2026-100953
• Device Sequence Number: 10652773
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: (01)00884838086760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 04/17/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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