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

Model Number	FC2010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the flex cardio sweep speed on the boom monitor abruptly changes to 400+ mm/sec.There was no reported patient impact / injury.
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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: 9249420
• Report Number: 1051786-2019-00045
• Device Sequence Number: 16994969
• Product Code: MWI
• UDI-Device Identifier: 00884838084919
• UDI-Public: (01)00884838084919
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 10/23/2019

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: 453564634211
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1