MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO 2010 REV E

Model Number	453564845831
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an emergency procedure the patient required defibrillation.The doctor shocked the patient about 11 times.The system asked 2 times to restart.The customer had to restart to continue the procedure so he could continue.The device was in use at time of event, it is unknown if there was any adverse event to patient at time of event.Additional information regarding this incident has been requested.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
After further investigation it was determined there was no patient harm to paitent.
Event or Problem Description
It was reported to philips that, during an emergency procedure the patient required defibrillation.According to the customer, the doctor shocked the patient about eleven (11) times and for at least two of them, the system displayed an error message that a restart was necessary.The device was reportedly restarted, and the procedure was continued without further issue.Subsequent information received indicated that the patient was not negatively impacted as a result of the reported issue.It was also confirmed that redundant monitoring was being used by staff at the time of the event.Additional patient information was requested from the customer; however, none was provided.The device was in clinical use at the time the reported issue was discovered.The patient's condition and/or procedure was one in which required the patient to be defibrillated.There was no allegation that the reported issue negatively impacted or delayed treatment of the patient.

• Brand Name: XPER FLEX CARDIO 2010 REV E
• Common Device Name: XPER FLEX CARDIO 2010 REV E
• 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: 13861207
• Report Number: 1051786-2022-00020
• Device Sequence Number: 20006691
• Product Code: MWI
• UDI-Device Identifier: 00884838093645
• UDI-Public: 00884838093645
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 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: 453564845831
• Device Catalogue Number: 453564845831
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2020
• 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: Hospitalization
• Patient Sex: Unknown