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

Model Number	453564667151
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Measurement System Incompatibility (2982)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that, during a patient procedure on (b)(6) 2022 at around 17:30 the patient required defibrillation.The customer reported that the first shock of 200 volts was ok, but the second shock at 360 volts caused the hemo device to become unresponsive.The customer reportedly waited for the signal to return and after thirty (30) seconds rebooted the fc2010 device to recover.The customer reports over one (1) minute of downtime.Remote support confirmed with the customer that the ecg, p1 (pressure channel 1), and nibp (non-invasive blood pressure) were connected to patient.According to remote support, these are defib-proof inputs and should only experience 5 seconds delay in signal after defib.In this case, normal operating mode did not return.Available information suggests that the patient's condition and/or procedure was one in which required the patient to be defibrillated.There was no adverse impact to the patient reported by the customer as a result of this incident.Onsite support has been dispatched to further evaluate the device.
Event or Problem Description
The customer reported that, during a patient procedure on 17-apr-2022 at around 17:30 the patient required defibrillation.The customer reported that the first shock of 200 volts was ok, but the second shock at 360 volts caused the hemo device to become unresponsive.The customer reportedly waited for the signal to return and after thirty (30) seconds rebooted the fc2010 device to recover.The customer reports over one (1) minute of downtime.Remote support confirmed with the customer that the ecg, p1 (pressure channel 1), and nibp (non-invasive blood pressure) were connected to patient.According to remote support, these are defib-proof inputs and should only experience ~ 5 seconds delay in signal after defib.In this case, normal operating mode did not return.Available information suggests that the patient's condition and/or procedure was one in which required the patient to be defibrillated.There was no adverse impact to the patient reported by the customer as a result of this incident.Onsite support has been dispatched to further evaluate the device.The patient reportedly had to be defibrillated during the procedure.There was no lasting impact to the patient reported by the customer as a result of this incident.
Additional Manufacturer Narrative
A philips field service engineer (fse) was dispatched to the customer's site to address the reported problem.According to service notes, log files were collected from the system for further review.However, the log files obtained only reflect the activity of the xper im and philips hemo app behavior, there is no relevant information pertaining to the flex cardio.Therefore, a root cause could not be determined.The fse also indicated that the system was soon to be replaced with the intellivue x3 patient monitor.The device failed to work as expected by the customer and was rebooted to resume monitoring.The xper flex cardio device was ultimately removed from service and replaced with the intellivue x3 patient monitor.A replacement system is now in use at the customer's facility.A search in salesforce found no further related calls.The absence of further calls supports that the reported problem was resolved.

• 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: 14406490
• Report Number: 1051786-2022-00028
• Device Sequence Number: 2479519
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: 00884838083820
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• 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: 453564667151
• Device Catalogue Number: 453564667151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• 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: Male