MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; XPER FLEX CARDIO 2010

Model Number	453564243591
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Measurement System Incompatibility (2982)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that use of a defibrillator was necessary during the case and, after defibrillating the patient, the ecg became flat and also monitoring off was displayed.A restart of the system was needed in order to resume function of the flex cardio.The device was in use at time of event and was reported that the patient passed away after being transferred to the iccu.
Event or Problem Description
It was reported that use of a defibrillator was necessary during the case and, after defibrillating the patient, the ecg became flat and also monitoring off was displayed.A restart of the system was needed in order to resume function of the flex cardio.The device was in use at time of event and was reported that the patient passed away after being transferred to the iccu.
Additional Manufacturer Narrative
The use of an instramed cardiomax 8 defibrillator was necessary during a pci (percutaneous coronary intervention) procedure and, after defibrillating the patient (with 200 volts), the ecg became flat and monitoring off was displayed on the examination room monitor (boom).The procedure was continued using another bedside monitor, and a restart of the system was reportedly required in order to resume monitoring function of the flex cardio device.According to the customer, the reported device issue did not cause or contribute to the patients death.The procedure was successfully completed with two (2) stent's implanted into the patient.The patient was then transferred to the iccu (intensive coronary care unit) and later passed away.No additional patient information has been provided by the customer.According to the customer, a reboot of the system was performed to resolve the issue.The problem has only occurred once and has not happened since.A philips field service engineer (fse) was dispatched to the customer's site to further evaluate the device and perform electrical safety tests.Per the attending fse, electrical safety tests (earthbound, ground, and touch current leakage) was performed on the actual device involved in this complaint and all measurements were found to be within normal range.The customer again confirmed that there have been no further issues when using the defibrillator and the system is functioning normally.The device passed all functional testing and was returned to service.The device did not behave as expected by the customer.To resolve the issue, a system reboot was performed.In addition, field service was sent onsite to perform electrical safety checks.The device passed all functional testing and remains in use at the customer's facility.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO 2010
• 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: 14495971
• Report Number: 1051786-2022-00032
• Device Sequence Number: 5769043
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: 00884838082113
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: 453564243591
• Device Catalogue Number: 453564243591
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2016
• 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: Death
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 48 KG