MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Multi Measurement Server X2; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	865039
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an intellivue multi measurement server x2 indicating that spo2 measurements could not be obtained and there is a suspicion that the spo2 measurement was inaccurate.During remote troubleshooting replacement of the sensor cable did not resolve the issue.The device was reported to be in clinical use but not in use on a patient.No adverse event to the patient or user was reported.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included efforts to reproduce the reported issue.The results of the analysis were the reported issue could not be reproduced.Functional testing was performed with the x2 both as a standalone unit and while connected to a host monitor.Spo2 measurements were obtained successfully in both configurations.No accessories or third-party devices were identified as contributing factors.Additional testing confirmed that after power-cycling the monitor, spo2 measurements were restored and operated normally.Further verification demonstrated successful spo2 measurements even after changing the cable.No abnormalities, error messages, or measurement failures were observed during the service visit.A subsequent follow-up confirmed that the issue remained absent after the device restart and that spo2 measurements continued to function normally.As the problem could no longer be reproduced and normal functionality was verified, no additional onsite service was required.The reported inability to obtain spo2 measurements could not be reproduced during philips' investigation.Functional testing confirmed normal spo2 operation following a power cycle.Although a parameter board issue was initially suspected based on customer-reported information, no hardware failure could be confirmed through testing.Based on the results of the analysis, the product malfunction was unable to be confirmed.As for precautionary measures, the system was power-cycled, and the product is back in service.A review of the service history for this device shows the problem has not been reported again for this device.Based on the information available and results of additional analysis, no further action is necessary at this time.

• Brand Name: IntelliVue Multi Measurement Server X2
• 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 ; +49(703)14632031
• MDR Report Key: 50777524
• Report Number: 9610816-2026-101906
• Device Sequence Number: 13202054
• Product Code: MHX
• UDI-Device Identifier: 00884838000261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 865039
• Device Catalogue Number: 865039
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2016
• 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