MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Patient Monitor MX500

Model Number	IntelliVue Patient Monitor MX500
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a preventive maintenance the device did not produce any audible apnea alarm.The device was not in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel who reached out to the customer multiple times for more information but the customer refused to provide more information.No diagnostics could be performed due to customer not responding to multiple good faith effort attempts to to provide more information.The product malfunction was unable to be confirmed because the customer refused service and did not respond to requests for additional information.A review of the service history for this device shows the problem has not been reported again for this device.E1: reporting institution phone#: (b)(6).E1: reporter phone#: (b)(6).

• Brand Name: IntelliVue Patient Monitor MX500
• Common Device Name: IntelliVue Patient Monitor MX500
• 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: 50916307
• Report Number: 9610816-2026-102035
• Device Sequence Number: 17580813
• Product Code: MHX
• UDI-Device Identifier: 00884838038776
• UDI-Public: (01)00884838038776
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: Other
• Device Model Number: IntelliVue Patient Monitor MX500
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2021
• 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