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

Model Number	453564675021
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a xper flex cardio device was having wave tracings freeze and intermittently signals.The philips technical consultant (tc) was unable to confirm the event.The tc went on site and ran testing, but was unable to duplicate the event.The tc did note that the settings needed to be adjusted for optimal performance.The cause of the event was unable to be determined.The tc corrected settings while on site.

• Brand Name: XPER FLEX CARDIO 2010 REV C RUEXCHANGE
• Common Device Name: XPER FLEX CARDIO 2010 REV C RUEXCHANGE
• 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: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15947820
• Report Number: 1051786-2022-00051
• Device Sequence Number: 12597815
• Product Code: MWI
• UDI-Device Identifier: 00884838102804
• UDI-Public: 00884838102804
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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: 453564675021
• Device Catalogue Number: 453564675021
• 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: Not provided
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2010
• 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