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

Model Number	866470
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer onsite to evaluate the device in question.The rse indicated during an evaluation of the system and speaking with the customer that the system did not completely freeze during this case.The rse confirmed with the customer that the device touchscreen did not respond to any command.The customer could not activate the nbp measurement or do anything at all.The rse confirmed with the nurse that the system touch screen froze for 3-4 minutes.After the reported incident there was no problems with monitor.The rse confirmed no additional repair or investigation was required.The philips remote service engineer (rse) confirmed the customer's device issue but confirmed no additional repair or investigation was required.
Event or Problem Description
Philips received a complaint on the intellivue mx850 patient monitor indicating the system freezes during patient use.The device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.

• 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: 19451894
• Report Number: 9610816-2024-00305
• Device Sequence Number: 15209930
• Product Code: MHX
• UDI-Device Identifier: 00884838070790
• UDI-Public: 00884838070790
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Report Date (Section B): 06/03/2024

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: 05/08/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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