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

Model Number	453564243601
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 nibp (non-invasive blood pressure) will give the same reading until manually getting one.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
H10: the customer reinstalled the flex cardio sw to resolve the issue and the device was returned to use.The customer also expressed an interest in purchasing new equipment since the revision they own is out of support.The customer was provided a quote and is working with their sales representative on this purchase.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: 10916214
• Report Number: 1051786-2020-00069
• Device Sequence Number: 13589563
• Product Code: MWI
• UDI-Device Identifier: 00884838083516
• UDI-Public: (01)00884838083516
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 11/19/2020

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: 453564243601
• Device Catalogue Number: 453564243601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/29/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1