MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO 2010 REV D; XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

Model Number	FC2010
Health Effect - Clinical Code	Death (1802)
Date of Event	09/23/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
Event or Problem Description
It was reported to philips that, on a patient with an external stimulation, the ecg waves are very spikey, and during a short period disappeared.The patient reportedly passed away.We are in the process of obtaining additional information.
Additional Manufacturer Narrative
H10: the ecg curve would exhibit artifact (noise / interference), and sometimes the wrong heart rate measurement.The customer did not allege that the device caused or contributed in any way to the patient¿s outcome, nor was treatment of the patient delayed as a result of the incident.No additional patient information has been provided by the customer.The device did not behave as expected by the customer.However, onsite field service was unable to confirm the reported problem during his evaluation.The fse suspects that the ecg issue was likely caused by the external stimulation used by the customer.This was also indicated in the log file review.The fse proactively installed two (2) ferrites on the power cord to minimize any potential artifact and confirmed the system's functionality.There is no evidence to suggest that the device contributed in any way to the patient¿s outcome.The device remains in use at the customer's facility.No further action or investigation is warranted based on the available information at the time of complaint closure submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Event or Problem Description
It was reported to philips that, on a patient with an external stimulation, the ecg waves are very spikey, and during a short period disappeared.The patient passed away.

• Brand Name: XPER FLEX CARDIO 2010 REV D
• Common Device Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 10623561
• Report Number: 1051786-2020-00048
• Device Sequence Number: 3258831
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: (01)00884838083820
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: FC2010
• Device Catalogue Number: 453564667151
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death