MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FC2010 REV E EXCHANGE

Model Number	453564845841
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone number (b)(6).
Event or Problem Description
It was reported to philips that, the invasive blood pressure real time waveform was displayed correctly, but its numerical values were not updated.The malfunction happened during an urgent cath-lab procedure.The customer noticed that the invasive pressure was decreasing on the displayed waveform, but the pressure numerical values were frozen.They did a snapshot and in the snapshot the pressure numerical values were correctly updated as expected.The device was in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.
Event or Problem Description
It was reported to philips that, "the invasive blood pressure real time waveform was displayed correctly, but its numerical values were not updated.The malfunction happened during an urgent cath-lab procedure.The customer noticed that the invasive pressure was decreasing on the displayed waveform, but the pressure numerical values were frozen.They did a snapshot and in the snapshot the pressure numerical values were correctly updated as expected.The device was in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.

• Brand Name: XPER FC2010 REV E EXCHANGE
• Common Device Name: XPER FC2010 REV E 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: tara mackinnon ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 12436437
• Report Number: 1051786-2021-10049
• Device Sequence Number: 11590349
• Product Code: MWI
• UDI-Device Identifier: 00884838093775
• UDI-Public: 00884838093775
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564845841
• Device Catalogue Number: 453564845841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• 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
• Patient Sex: Unknown