MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX850 PATIENT MONITOR

Model Number	866470
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
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 there were issues with measuring spo2 with the masimo sensors on an icu patient.Several extra blood gases were drawn and staff had to try to warm the patient.The ventilator's oxygen level was increased.It was indicated the spo2 values did not correlate with the blood gas analysis though multiple sensors were tried; however, not specific values were provided.The customer indicated there was no impact to the patient.
Additional Manufacturer Narrative
Additional information was received that indicates the patient was on an anti-hypertensive medication (dobutamine and norepinephrine).The patient probes were tested on the nurse and good spo2 results were not observed.Extra blankets were placed on the patient in an attempt to warm the hands.The exact blood gas measurement and spo2 perfusion values were missing from the patient's medical record, so those cannot be provided.The patient was in the icu being monitored for cardiac arrest at the time of the event and the reported issue did not have an impact on the patient's outcome.The issue was resolved and the customer indicated this was achieved by placing the patient's hands with the spo2 probe under the covers.Good faith efforts (gfes) are ongoing to clarify the root cause.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The cause of the reported problem was ambient light interference.References in the instruction for use (ifu) state spo2 interference can be caused by high levels of ambient light, strobe lights or flashing lights.Additionally, there is a caution in the ifu that loss of pulse signal can occur when the patient is in cardiac arrest.Masimo had been contacted to inform them about the issue and to find out if this is a known issue to them.Masimo staff stated they are aware of the issue of ambient light affecting the accuracy of the spo2 measurement and they provide light shield products for the customer to limit the influence of ambient light on the spo2 measurement.The customer stated they were able to resolve the issue themselves by placing extra blankets on the patient's hands to warm them and to cover the sensors for the light.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 MX850 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX850 PATIENT MONITOR
• 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: 21064909
• Report Number: 9610816-2025-000002
• Device Sequence Number: 3279124
• Product Code: MHX
• UDI-Device Identifier: 00884838070790
• UDI-Public: (01)00884838070790
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K210906
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2025

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: 866470
• Device Catalogue Number: 866470
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 03/26/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/14/2025; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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