MAUDE Adverse Event Report: INVIVO CORPORATION PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM; PHYSIOMONITORYING SYSTEM, INFO

Model Number	FC2010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue was confirmed.The cause of the event is unknown.It is unknown if the issue has been resolved.The device remains onsite.
Event or Problem Description
The customer reported that the device is set at 25 and is showing 50.The device was in use at the time of the event.No adverse event involving a patient was reported.

• Brand Name: PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM
• Common Device Name: PHYSIOMONITORYING SYSTEM, INFO
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 11715245
• Report Number: 1051786-2021-00011
• Device Sequence Number: 17148083
• Product Code: MWI
• UDI-Device Identifier: 00884838084902
• UDI-Public: (01)00884838084902
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: FC2010
• Device Catalogue Number: 453564634201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1