MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; XPER FLEX CARDIO FC2010 REV C

Model Number	453564634201
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Measurement System Incompatibility (2982)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2022
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 the ekg goes flat when using a defibrillator.Customer is requesting onsite support to further evaluate the device.The device was in use at time of event.Further information as has been requested on patient.
Additional Manufacturer Narrative
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 fse could not reproduce the customer's reported problem.The device was reimaged for customer assurance and tested.The device passed all functional testing and was returned to service.The device did not behave as expected by the customer.However, 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 attending fse reimaged the device and confirmed functionality.The absence of further calls supports that the reported problem has not reoccurred or was resolved.The device remains in use at the customer's facility.
Event or Problem Description
The customer reported that the ekg goes flat when using a defibrillator.Customer is requesting onsite support to further evaluate the device.The device was in use at time of event.Further information as has been requested on patient however made not available at time of report.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO FC2010 REV C
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14495139
• Report Number: 1051786-2022-00031
• Device Sequence Number: 12299773
• Product Code: MWI
• UDI-Device Identifier: 00884838084902
• UDI-Public: 00884838084902
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• 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: 453564634201
• Device Catalogue Number: 453564634201
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2017
• 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: Other
• Patient Sex: Unknown