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

Model Number	FC2010
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.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.
Event or Problem Description
The customer reported that the sweep speed changes by itself.The device was in clinical use at the time the reported issue was discovered.There was no reported patient impact / injury.
Additional Manufacturer Narrative
H10: remote technical support emailed the customer some troubleshooting steps and advised that prior to changing out the device, they would like to log in and troubleshoot the issue.Good faith efforts (gfe) have been made by technical support to verify if the troubleshooting steps provided resolved the issue or if additional assistance was required.The customer has not responded to any of technical supports attempts and no additional information has been provided by the customer.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: PHILIPS XPER FLEX CARDIO PHYSIOMONITORIG SYSTEM
• Common Device Name: PHYSIOMONITORYING SYSTEM, INFO
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 11066180
• Report Number: 1051786-2020-00072
• Device Sequence Number: 16312744
• Product Code: MWI
• UDI-Device Identifier: 00884838084902
• UDI-Public: (01)00884838084902
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: FC2010
• Device Catalogue Number: 453564634201
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1