MAUDE Adverse Event Report: Philips Medical Systems Xper Flex Cardio Physiomonitoring System; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Model Number	Xper Flex Cardio 2010 Rev E
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• Brand Name: Xper Flex Cardio Physiomonitoring System
• Common Device Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
• Manufacturer (Section D): Philips Medical Systems; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): Philips Medical Systems; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 12151 research parkway; orlando, FL 32826 ; +1(407)275-3220
• MDR Report Key: 50868930
• Report Number: 1051786-2026-100066
• Device Sequence Number: 16124950
• Product Code: MWI
• UDI-Device Identifier: 00884838093645
• UDI-Public: (01)00884838093645
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: Xper Flex Cardio 2010 Rev E
• Device Catalogue Number: 453564845831
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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
• Patient Sex: Unknown