MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; XPER FLEX CARDIO 2010 REV D

Model Number	XPER FLEX CARDIO 2010 REV D
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone number (b)(6).
Event or Problem Description
The customer reported problems with nbp measurement.During operation, the monitor showing ecg signals froze.There was no reported patient impact / injury.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included testing of the actual device involved.The results of the analysis confirmed the device did not behave as expected.Based on the results of the analysis, it was determined that the product has malfunctioned.The cause of the reported problem was not established; however, it appears to be related to the software of the flex cardio device.The issue was resolved by replacing the flex cardio 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.This report is in reference to mfr report number 1051786-2021-10001.The case was re-opened review, and corrections have been made to bring the report up to current standards.
Event or Problem Description
Philips received a complaint on an xper flex cardio 2010 rev d indicating that during operation, the monitor showing ecg signals froze.The device was in use on a patient at time of event, there was no adverse event reported.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO 2010 REV D
• 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: 11445264
• Report Number: 1051786-2021-10001
• Device Sequence Number: 17024935
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: (01)00884838083820
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (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
• Report Date (Section B): 10/16/2025

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 FLEX CARDIO 2010 REV D
• Device Catalogue Number: 453564667151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2018
• 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