MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	Xper Flex Cardio Physiomonitoring System
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included system tests.The results of the analysis indicated the unit was working well with no issues; however, 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 timed out and the patient went into respiratory arrest during a restart.The customer indicated the customer noticed the arrest when the patient became unresponsive.Additional information was not provided; therefore, good faith efforts are being performed.
Event or Problem Description
Philips received a complaint on an xper fc2010 rev e exchange device indicating that the device timed out and the patient went into respiratory arrest during a restart.The customer indicated they noticed the arrest when the patient became unresponsive.Additional information was requested related to the patient outcome, interventions required and device contribution; however, it was not provided, despite multiple requests.
Additional Manufacturer Narrative
Analysis was performed by a field service engineer (fse) which included system tests.The results of the analysis indicated the unit was working well with no issues.Based on the results of the analysis, the product malfunction was unable to be confirmed.As for precautionary measures, xper fc2010 device was replaced.A review of the service history for this device shows the problem has not been reported again for this device.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: deborah currlin ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 25530744
• Report Number: 1051786-2026-100037
• Device Sequence Number: 18541338
• Product Code: MWI
• UDI-Device Identifier: 00884838093645
• UDI-Public: (01)00884838093645
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Xper Flex Cardio Physiomonitoring System
• Device Catalogue Number: 453564845831
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Supplement Date Received by Manufacturer: 08/25/2026; 08/27/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 08/27/2026; 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown