MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE

Model Number	453564243591
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nibp (non-invasive blood pressure) readings keep repeating.The device was not in clinical use.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 10214942
• Report Number: 1051786-2020-00034
• Device Sequence Number: 11413927
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: (01)00884838082113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: 453564243591
• Device Catalogue Number: 453564243591
• Device Lot Number: N/A
• 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: 06/24/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1