MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI-MEASUREMENT MODULE X3

Model Number	INTELLIVUE X3
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received from a philips clinical engineer stated paediatric patient was intubated and the monitor showed saturations of 0% despite a very good pleth trace, blood pressure, and heart rate.They were giving 100% oxygen, but the monitor still said 0%.The device was returned to the philips repair bench.A bench repair technician (brt) tested the device.The unit connected to host monitor without any issues.The device was unstable when connecting the hose to microstream port.The module was struggling to function.The brt replaced the co2 module and carried out verification tests; the device passed testing.Additional information was requested, but no further information was able to be obtained from the customer based on the information available and the testing conducted, the cause of the reported problem was related to the hose connection to the mircostream port.The reported problem was confirmed.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.E1: reporting institution phone #:(b)(6).Reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on an intellivue microstream extension.It was reported the spo2 measurement displayed 0%, though the ventilated patient was on 100% oxygen.A dynamp was connected to the patient, displaying spo2 of 97%.The customer indicated there was severe harm; however, no additional details of the alleged harm have been provided.It was indicated by the customer 'pediatric patient was intubated and the monitor showed sats of 0% despite a very good pleth trace, bp, and hr.We were giving 100% oxygen, but the monitor still said 0%.We also then lost our end tidal co2 monitoring trace.We got a dynamap and spo2 showed 97%.We changed the etco2 monitor and we got a good trace.This caused us to go down a different route of management, because we thought we were not able to oxygenate the patient.We removed the endotracheal tube, reinserted it, and in that time patient's spo2 dropped significantly.This was the monitor that was in the pediatric bay'.The sequence of events provided did not clarify the reasons for reintubation or the 'different route of management'.
Additional Manufacturer Narrative
Product information corrected to an intellivue multi-measurement module x3, based on additional information received on 09oct2025.

• Brand Name: INTELLIVUE MULTI-MEASUREMENT MODULE X3
• Common Device Name: INTELLIVUE MULTI-MEASUREMENT MODULE X3
• 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: 23077179
• Report Number: 9610816-2025-000843
• Device Sequence Number: 13196205
• Product Code: MHX
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171801
• 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,Followup
• Report Date (Section B): 10/09/2025

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 X3
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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