MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO PHYSIOMONITORING SYSTEM

Model Number	453564634201
Medical Device Problem Codes	No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	03/11/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The staff had to reboot the fc2010 to get the monitoring to return.During this timeframe, they did have an alternate ecg being watched on the defib machine.They performed subsequent shocks with no further issues.Once the case, was done, the biomed came and swapped the fc2010 device with a spare device.The customer did confirm that due to the patients prior condition that the fc2010 device did not have any affect on the outcome.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that they had a very sick patient come into the lab that they had to do cpr on.Staff used the defibrillator and when they did the first shock, the fc2010 device went blank on the boom and control room (host) showed an off message.The patient died.
Additional Manufacturer Narrative
A philips field service engineer (fse) was dispatched to the customer's site to address the reported problem.The device evaluation was performed by the fse on the actual device involved in this complaint.According to the fse, the spare device is currently in service.The fse brought the device in question back into the cath lab and thoroughly tested it.The fse reportedly reimaged the device but noted that the device was functioning as intended before and after the reimage.The device passed all functional testing and was returned to the customer for clinical use.Customer will use this device as the new spare.The device did not behave as expected by the customer and was replaced by biomed with an on hand spare.Onsite field service was unable to confirm the reported problem during his evaluation.Because of this, we are considering this to be a malfunction of cause unknown.The device in question was reimaged and functionality confirmed.A replacement device is now in use at the customer's facility.Subsequent to the receipt of this complaint, an issue impact assessment (iia-2975-2022-511) was submitted for the issue reported.Any additional investigation or action taken will be documented in the respective record.
Event or Problem Description
The customer reported that they had a very sick patient come into the lab that they had to perform cpr (cardiopulmonary resuscitation) on.Staff used a defibrillator and when they did the first shock, the fc2010 device went blank on the boom monitor and the control room (host pc) displayed an off message.The pci (percutaneous coronary intervention) was unsuccessful and the patient expired.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Common Device Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14013342
• Report Number: 1051786-2022-00025
• Device Sequence Number: 5104114
• Product Code: MWI
• UDI-Device Identifier: 00884838084902
• UDI-Public: 00884838084902
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 453564634201
• Device Catalogue Number: 453564634201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 115 KG