MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; CARDIOVASCULAR MONITOR

Model Number	453564241901
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 stated that there is a problem with measurement of ecg or blood pressure intermittently.The scanning speed (sweep speed) as well as the heart rate calculated as a function of the ecg were incorrect.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: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: CARDIOVASCULAR MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 10442019
• Report Number: 1051786-2020-00042
• Device Sequence Number: 16833605
• Product Code: MWI
• UDI-Device Identifier: 00884838083523
• UDI-Public: (01)00884838083523
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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: 453564241901
• Device Catalogue Number: 453564483321
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1