MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX800

Model Number	INTELLIVUE PATIENT MONITOR MX800
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported the device is not alarming with sound only visual at the bedside.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed remote service personnel which included talking to the customer and remoting into the system.The results of the analysis were that when the remote support engineer (rse) checked the clinical audit trail he noted that at approximately the same time that the issue is reported, the low hr alarm limit was changed to a low of 40.This may account for why the alarm was not heard, if the patient hr did not drop below the limit.The customer was advised the hear rate (hr) would need to drop to 39 in this case in order to activate the alarm.If the hr low clamp is set to 40, no yellow alarm would be heard, only a red alarm, as this rate would be below the clamp.The rse identified the alarm reflection master and proceeded to reboot with permission from biomed.After the ai master was rebooted, the issue persisted once again.The biomed adjusted alarm limits to 20 above the current hr.Again, the alarms were heard at the picix but not at the bedside monitor.The rse advised the biomed to test an empty bed using an mx40 and simulator to see if this is a widespread issue.The biomed stated he will test the system with mx40 and simulator.He will also use his ivst to clone a spare mx800 from a known good configuration.No further information is available as the customer did not come back and advised to have the order for onsite service closed.Based on the results of the analysis, it was determined that the product has malfunctioned but the cause remains unknown as the customer refused our service.A review of the service history for this device shows the problem has not been reported again for this device.

• Brand Name: INTELLIVUE PATIENT MONITOR MX800
• Common Device Name: INTELLIVUE PATIENT MONITOR MX800
• 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: 24532931
• Report Number: 9610816-2026-100457
• Device Sequence Number: 21066295
• Product Code: MHX
• UDI-Device Identifier: 00884838020733
• UDI-Public: (01)00884838020733
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 05/05/2026

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 MX800
• Device Catalogue Number: 865240
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2018
• 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