MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. XPER INFORMATION MANAGEMENT SYSTEM; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	XPER INFORMATION MANAGEMENT SYSTEM
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the xper information management system (xperim) software was not able to launch while the patient was being prepped for the procedure.The user attempted to launch xperim but to no avail.It was confirmed there was no patient harm.The device was in clinical use at the time of the event.While xperim software is primarily intended for information management during procedures.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigation is on-going.Philips will provide another report in 30 days.
Event or Problem Description
It was reported to philips that the xper information management system (xperim) software was not able to launch while the patient was being prepped for the procedure.The user attempted to launch xperim but to no avail.It was confirmed there was no patient harm.The device was in clinical use at the time of the event.While xperim software is primarily intended for information management during procedures.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips investigation is on-going.Philips will provide another report in 30 days.
Event or Problem Description
It was reported to philips that the xper information management system (xperim) software was not able to launch while the patient was being prepped for the procedure.The user attempted to launch xperim but to no avail.It was confirmed there was no patient harm.The device was in clinical use at the time of the event.While xperim software is primarily intended for information management during procedures.
Event or Problem Description
It was reported to philips that the xper information management system (xperim) software was not able to launch while a patient was being prepped for a procedure.It was confirmed there was no patient harm.The investigation indicated that the problem occurred while the staff was prepping the patient.The staff attempted to start up xperim and it failed to launch.Based on the results of the analysis, the cause of the reported problem was that the datacenter was out of memory, therefore xperim was unable to reach out and start the communication with the datacenter.This caused xperim to become unresponsive and it failed to start.Performing a restart of the datacenter application restored functionality and resolved the issue.Philips performed an assessment and found the reported issue could not lead to death or serious injury should it recur.

• Brand Name: XPER INFORMATION MANAGEMENT SYSTEM
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: benny lam ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 20579390
• Report Number: 3003768277-2024-06251
• Device Sequence Number: 15480265
• Product Code: MWI
• UDI-Device Identifier: 00884838100084
• UDI-Public: 00884838100084
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/17/2025

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: XPER INFORMATION MANAGEMENT SYSTEM
• Device Catalogue Number: 830230
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 10/14/2024; 10/14/2024; 10/14/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/27/2024; 12/19/2024; 01/17/2025
• 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