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

Model Number	453564483321
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 reported that the time is off by 5 minutes when synching.It was reported by the customer that, they are noticing the waves are not synching up from the boom to the control room, and it appears to be about 5 minutes of a difference.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: 9344928
• Report Number: 1051786-2019-00052
• Device Sequence Number: 11523665
• Product Code: MWI
• UDI-Device Identifier: 00884838083523
• UDI-Public: (01)00884838083523
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 453564483321
• 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: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1