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

Model Number 453564483321

Device Problems Electrical /Electronic Property Problem (1198); Date/Time-Related Software Problem (2582)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review.

Event Description

The customer reported that the host and flex cardio boom screens have different times and also are not always in sync.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Type of Device: CARDIOVASCULAR MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: kimberly shelly ; 12151 research parkway; suite 200; orlando, FL 32826
• MDR Report Key: 11711735
• MDR Text Key: 249248466
• Report Number: 1051786-2020-00053
• Device Sequence Number: 1
• Product Code: MWI
• UDI-Device Identifier: 00884838083523
• UDI-Public: (01)00884838083523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 453564483321
• Device Catalogue Number: 453564483321
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1