MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE

Model Number	453564243591
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 a speaker malfunction.The device was not in clinical use at the time the reported issue was discovered.
Additional Manufacturer Narrative
H10: the field service engineer (fse) discovered that the speaker the customer was referring to is a third party accessory that is used between the examination and control rooms that allows the doctor to communicate with the radiologist and nurse.The fse contacted the third party vendor and had the speaker replaced to resolve the issue.The fse confirmed there was no speaker malfunction or failure of the flex cardio device and that all audible sounds/alarms could be heard from the device at all times.The device passed all functional testing and was returned to service.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: PHYSIOMONITORING SYSTEM MANAGEMENT DEVICE
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 10276719
• Report Number: 1051786-2020-00038
• Device Sequence Number: 19489113
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: (01)00884838082113
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 453564243591
• Device Catalogue Number: 453564243591
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1