MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; PHYSIOMONITORYING SYSTEM, INFO

Model Number FC2010

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported by the technical support engineer (tse), that the flex cardio (rev c) nic needs to be set to 100 full instead of industry standard auto negotiate.When set to auto negotiate there are issues with the alarms and they do not function properly, in that they do not always turn on when there is an issue outside of the predetermined limits.If the flex cardio (rev c) is set to 100 full, it functions properly.There was no reported patient impact.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Type of Device: PHYSIOMONITORYING SYSTEM, INFO
• 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: denyse murphy ; 12151 research parkway; suite 200; orlando, FL 32826
• MDR Report Key: 6471236
• MDR Text Key: 72442621
• Report Number: 1051786-2017-00008
• Device Sequence Number: 1
• Product Code: MWI
• 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,Followup
• Report Date: 03/10/2017

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
• Device Operator: Health Professional
• Device Model Number: FC2010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: 03/10/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1