MAUDE Adverse Event Report: INVIVO CORPORATION XPER FC2010 REV E EXCHANGE

Model Number	453564845841
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
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 during a coronary angiography while monitoring the heart rhythm of a patient, a break occurred and lasted 5 minutes.After checking the connections to the patient and the equipment, the ecg signal only resumed after the balloon, which is used to monitor the patient's vital parameters during the examination had been switched off and on again.
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site.The fse evaluated the device and determined that the device required replacement.The device was replaced and handed back over to the customer working as specified.
Event or Problem Description
The customer reported that during a coronary angiography while monitoring the heart rhythm of a patient, a break occurred and lasted 5 minutes.After checking the connections to the patient and the equipment, the ecg signal only resumed after the balloon, which is used to monitor the patient's vital parameters during the examination had been switched off and on again.

• Brand Name: XPER FC2010 REV E EXCHANGE
• Common Device Name: XPER FC2010 REV E EXCHANGE
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer (Section G): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer Contact: jeanne ahearn ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 15550140
• Report Number: 1051786-2022-00048
• Device Sequence Number: 6180801
• Product Code: MWI
• UDI-Device Identifier: 00884838093775
• UDI-Public: 00884838093775
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 453564845841
• Device Catalogue Number: 453564845841
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown