MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue MX500 Patient Monitor; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue Patient Monitor MX500
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the intellivue mx500 patient monitor indicating that the monitor intermittently generates false ventricular tachycardia red alarms when the patient had a high heartrate with atrial fibrillation rhythms.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with biomed regarding intermittent false red v-tach alarms during high heart rate and afib rhythms.No device failure, error codes, patient impact, or accessory contribution were identified.The rse reviewed ecg analysis and found normal beat labels with occasional pvc labels, heart rates ranging from approximately 90 to above 100 bpm, and high-heart-rate yellow alarms.The rse explained the philips st/ar arrhythmia guidance and instructed the user to change ecg analysis from multilead to single-lead, review each ecg lead waveform, and select the lead with the best signal quality when necessary.The rse emailed the pic ix ecg analysis quick guide to biomed, who shared it with staff and reported improved understanding of what to monitor.Biomed agreed to monitor the behavior, and the system met specifications for the performed service and was returned to use.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: IntelliVue MX500 Patient Monitor
• 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: 50899388
• Report Number: 9610816-2026-102014
• Device Sequence Number: 20290885
• Product Code: MHX
• UDI-Device Identifier: 00884838038776
• UDI-Public: (01)00884838038776
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131872
• 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): 09/25/2026

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 Patient Monitor MX500
• Device Catalogue Number: 866064
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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