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

Model Number	453564667151
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the system shut down in the middle of patient coding, would like someone to look at patient logs.The customer indicated patient harm; however, no details were provided.Additional information was requested; however, patient status and event details are unknown.A philips remote service engineer (rse) assisted the biomed with the logs and there was no relevant device data found during the time frame of the alleged failure.In addition, the rse identified the device was not being shutdown in order to prevent failures during cases and that there has not been any preventative maintenance (pm) performed on devices.The customer was provided with documentation on these procedures so they can perform pm work, and the staff was instructed that these devices need to be shutdown and restarted daily before cases are performed.At this time, there is insufficient information to determine if the device caused or contributed to the reported patient event.The event details were reviewed by a philips sr.Product support engineer who stated the likely cause of the event is the flex cardio was over energized past the bounds of our specifications.
Additional Manufacturer Narrative
This was originally reported under mfr report number 3003768277-2023-02190 the remote service engineer (rse) confirms that the issue was resolved by restarting the device.The device was operational after the device was restarted.The device logs were reviewed by a philips sr.Product support engineer who stated the likely cause of the event is the flex cardio was over energized past the bounds of our specifications.The instructions for use (ifu) provides a precaution of interference issues with electrosurgical devices.Based on the information available, the cause of the reported problem is the user not performing the proper shut down procedure on the device.

• 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: hisham alzayat ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 16904627
• Report Number: 1051786-2023-00006
• Device Sequence Number: 17851763
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: 00884838083820
• Combination Product (Y/N): N
• 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

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: 453564667151
• Device Catalogue Number: 453564667151
• 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: 04/10/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• 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: Required Intervention
• Patient Sex: Unknown