MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; PATIENT MONITOR

Model Number	453564243591
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.Information not available at time of report.
Event or Problem Description
The customer reported that, during a procedure, a delay of approximately 10 seconds was noted between the plot and the actual data.The patient had a cardiac arrest, the delay observed of which is apparently not the cause, but which was detected with these 10 seconds of delay.A request for additional information regarding this incident has been sent.
Additional Manufacturer Narrative
Additional information received indicated that, on (b)(6) 2020 between 10am and 1pm during an aortic valve procedure, there was a delay of 10 seconds between the ecg display and the external electro stimulation.The patient went into cardiac arrest during this time and had to be connected to an external ecg monitor/defibrillator for resuscitation.The customer rebooted the xper flex cardio device and the issue was resolved.There was no lasting impact to the patient reported as a result of this incident.A philips field service engineer (fse) was dispatched to the customer's site to address the reported problem.According to the attending fse, the system was in use and not available for evaluation.This issue reportedly has only occurred once and the system has been functioning as intended since the reboot was performed by the customer.The fse further indicated that, after speaking with staff that the device is almost never restarted.The customer was advised to reboot the system on a regular basis.No further repair activity was deemed necessary by onsite support.The absence of further calls supports that the reported problem has not reoccurred and was resolved.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.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 10223289
• Report Number: 1051786-2020-00037
• Device Sequence Number: 536105
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: (01)00884838082113
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564243591
• Device Catalogue Number: 453564243591
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1