MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	INTELLIVUE MP5
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed remotely by philips remote service personnel.At the time of troubleshooting, the biomed was not physically present with the monitor.The remote application specialist (ras) provided guidance to ensure the spo2 sensor was properly applied, with the emitter and detector directly opposite each other, and recommended placement on the patient¿s non-dominant ring finger to minimize motion artifact.Additional recommendations included applying ecg monitoring for pulse/heart rate verification and reviewing the qrs detection settings through ecg > touch hr > scroll down to qrs detection.The ras explained that the qrs detection sensitivity may require adjustment to prevent counting both the r and t waves.If double counting persisted with ecg monitoring, it was recommended to select an ecg lead with a taller r wave and shorter t wave morphology.The biomed indicated they would work with clinical staff to implement the recommendations and resolve the issue.The biomed later responded that the qrs detection option had been verified on the monitor and that staff had been advised regarding alternate sensor placement options.No additional information regarding the reported issue was provided.The patient associated with the event had since been discharged, limiting any further evaluation or replication attempts.The root cause of the reported issue could not be determined.A review of the device service history identified no additional reports of this issue for the affected device.
Event or Problem Description
Philips received a complaint on a intellivue mp5 indicating that spo2 pulse is double counting resulting in false extreme high pulse alarms.The device was in use on a patient at the time of event, no adverse event was reported.

• Brand Name: INTELLIVUE MP5
• 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: 25163422
• Report Number: 9610816-2026-100929
• Device Sequence Number: 10646287
• Product Code: MHX
• UDI-Device Identifier: 00884838000230
• UDI-Public: (01)00884838000230
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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 MP5
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2017
• 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