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

Model Number	453564241901
Medical Device Problem Codes	Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that during a defib-implantation procedure, the ecg curves flat lined and there was no spo2 displayed.Patient outcome is currently unknown.
Additional Manufacturer Narrative
Subsequent information received indicated that, the patient was undergoing an implantable cardioverter-defibrillator (icd) procedure when the fc2010 device lost vitals and had to be restarted to resume monitoring.According to the customer, there was no patient harm, nor was the patient negatively impacted as a result of the incident.The icd procedure was successfully completed.The available information suggests that staff was likely testing the icd during the operation when the issue occurred, however we have been unable to confirm this, nor have we been able to determine what was happening immediately prior to the loss of monitoring (if any electrosurgical equipment was in use, or if the loss of monitoring was completely spontaneous).Additional patient information was requested from the customer; however, none has been provided.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, functional tests of the xper flex cardio device was carried out and pressure inputs p1-p4 calibrated.All vital parameters were reportedly displaying according to the specification and there were no technical errors observed.The device passed all functional testing and was returned to service.A search in salesforce found no further related calls.The device did not behave as expected by the customer and was rebooted to resolve the issue.Onsite field service was unable to confirm the reported problem during testing.Because of this, we are considering this to be a malfunction of cause unknown.The absence of further calls supports that the reported problem has not reoccurred.The device remains in use at the customer's facility.In addition, a issue impact assessment (iia-2975-2022-511) was submitted for the issue reported (fc2010 recovery from defibrillator and/or electro-surgical device use).Any additional investigation or action taken will be documented in the respective record.
Event or Problem Description
It was reported to philips that, during a defib-implantation procedure, the ecg curves flat lined, and there was no spo2 displayed.The device was in clinical use at the time the reported issue was discovered.

• 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: 14917225
• Report Number: 1051786-2022-00035
• Device Sequence Number: 16614807
• Product Code: MWI
• UDI-Device Identifier: 00884838103610
• UDI-Public: 00884838103610
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564241901
• Device Catalogue Number: 453564241901
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2013
• 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