MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Multi Measurement Server SLCP; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	IntelliVue Multi Measurement Server SLCP
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is not reading ecg values correctly.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 spoke to the customer biomed who stated that the ecg is not providing the correct values.The biomed was requesting parts identification for a replacement ecg-5ld/masimo spo2/w pt nrohs pca board.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 faulty ecg-5ld/masimo spo2/w pt nrohs pca board.The biomed was provide parts identification and a quote for a replacement pca ecg-5ld/masimo spo2/w pt nrohs board.The customer is taking responsibility for servicing the device.

• Brand Name: IntelliVue Multi Measurement Server SLCP
• 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: 50191877
• Report Number: 9610816-2026-101617
• Device Sequence Number: 21334426
• Product Code: MHX
• UDI-Device Identifier: 00884838055094
• UDI-Public: (01)00884838055094
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150975
• 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): 08/10/2026

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 Multi Measurement Server SLCP
• Device Catalogue Number: 866462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2019
• 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