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

Model Number	FC2010
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review.
Event or Problem Description
The customer reported that the monitor did not display correctly.The device was not in clinical use at the time the issue was discovered.There was no adverse event or patient harm 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: 11686306
• Report Number: 1051786-2020-00052
• Device Sequence Number: 14624909
• 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): 11/08/2017

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: 11/08/2017
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1