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	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After restarting the device everything worked again.The customer reported the issue as intermittent.A philips field support engineer (fse) visited the customer site, but the customer advised that the reported error is currently no longer present.The customer will report the issue if the error recurs.The issue is currently no longer present or reproducible, but the reported problem was confirmed.The device remains in use.If additional information is received the complaint file will be reopened.Reporting address state: 07 h3 other text : see h10.
Event or Problem Description
It was reported that the ground floor electrocardiogram (ecg) signal was frozen during the examination.However, the pressure continued to run correctly.The device was 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: 19096252
• Report Number: 1051786-2024-00002
• Device Sequence Number: 7607383
• 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: Nurse
• 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: 04/03/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2016
• 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
• Patient Sex: Unknown