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

Model Number	453564483321
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) went onsite to the customer facility to evaluate the reported issue.The following functional tests were performed: the fse performed device testing and confirmed the issue of the ecg freezing on the flexcardio device.The fse replaced the flexcardio front end with a loaner device and observed the uninterrupted ecg signal for 3 hours.Results of functional testing indicate that the flexcardio front end malfunctioned and required replacement.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the flexcardio device front end.The reported problem was confirmed.The customer was provided a loaner device to resolve the issue.The customer has stated that their intention is to purchase an intellivue x3 to replace the flexcardio system in the near future.It has been concluded that no further action is required at this time.
Event or Problem Description
It was reported that the electrocardiogram (ecg) image on the flexvision monitor freezes.The device was not in use on a patient at the time of the event, there was no adverse event reported.

• Brand Name: XPER FLEX CARDIO 2010 REV-B-EXCHANGE
• Common Device Name: XPER FLEX CARDIO 2010 REV-B-EXCHANGE
• 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: 16981586
• Report Number: 1051786-2023-00007
• Device Sequence Number: 6931867
• Product Code: MWI
• UDI-Device Identifier: 00884838083523
• UDI-Public: 00884838083523
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 453564483321
• Device Catalogue Number: 453564483321
• 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: 01/04/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2012
• 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