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

Model Number	453564621791
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a pulmonary vein isolation examination of a patient under general anesthesia, the patient had to be reanimated in the procedure, and the hemo monitoring was frozen.According to the customer, there was no live ecg monitoring in either the examination room or in the control room.Rebooting the box fixed the problem.
Additional Manufacturer Narrative
Section b event date was corrected.A philips field service engineer (fse) was dispatched to the customer's site to address the reported problem.The device evaluation was performed by the fse on the actual device involved in this complaint.According to service notes, the customer's reported problem could not be duplicated / replicated during the service call.The described disturbance (ecg failure when using defib) reported on 23-feb-2022 has not repeated since initially being reported and other similar procedures have successfully been carried out.In an effort to further assist the customer, it was recommended that staff attach the ecg electrodes as far as possible towards the extremities and away from the defibrillator during use.The device passed all functional testing and was returned to service.The device remains in use at the customer's facility.
Event or Problem Description
It was reported to philips that, during a pulmonary vein isolation (pvi) examination of a patient under general anesthesia, the patient had to be reanimated in the procedure, causing the hemodynamic monitoring to become unresponsive.Available information suggests that the patient's condition and/or procedure was one in which required the patient to be defibrillated.According to the customer, there was no live ecg monitoring in either the examination room or in the control room and a reboot of the system had to be performed to resolve the issue.Subsequent information received indicated that, it was not possible for staff to follow how the patient's ecg developed during the resuscitation.It was reported that comparable monitoring was not available, staff was able to use the monitor of the anesthesia unit until the flex cardio device was rebooted, but feel this did not offer a sufficient view for all users.Additional patient information was requested from the customer; however, none has been provided.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• 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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13839941
• Report Number: 1051786-2022-00019
• Device Sequence Number: 11763028
• Product Code: MWI
• UDI-Device Identifier: 00884838084926
• UDI-Public: 00884838084926
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564621791
• Device Catalogue Number: 453564621791
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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: Required Intervention
• Patient Sex: Unknown