MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO 2010 REV D; XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

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 cath lab received a patient from the emergency department in emergent cardiac distress with a diagnosed st elevated myocardial infarction = heart attack in process.According to the customer, at the very beginning of the procedure, the clinical team was not able to zero the invasive pressure channels p1 or p2 that receive the patient's invasive pressure that is presented by the back-plate and pressure capsules of the bracco acist cvi power injections system.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 2010 REV D
• Common Device Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 9345029
• Report Number: 1051786-2019-00053
• Device Sequence Number: 16869435
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: (01)00884838083820
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/14/2019

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: 453564667151
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1