MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO 2020 REV D EXCHANGE

Model Number	453564675001
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the fc2010 stopped populating vitals during case while patient was coding.The customer reported ecg tracing was not available, no non-invasive measurements (bp, hr, spo2), and no arterial tracings were functional and displayed.The fc2010 was not connected to other devices.The patient continued to be appropriately resuscitated.The impella (ventricular assist device) was used for the patient's arterial tracing.This did not lead to harm to the patient as the staff was able to see arterial tracings using the impella device while troubleshooting the flex cardio for three minutes.Appropriate resuscitation continued, but the user was more concerned with proper documentation of the vital signs with regard to the device issue.There was no indication this issue resulted in any additional harm to the patient.A philips remote service engineer (rse) interviewed the customer to evaluate the device in question.The rse provided the customer with the fc2010 preventive xper ifu documentation to customer to review.The rse recommended, if possible, to power drain the fc2010 to restart the fc2010\hemo app station daily, or monday mornings, before each case.The rse was not able to determine the cause of the fc2010 failure.The rse checked the hemo application wks remotely to oversee the local database size and to reconfigure it if needed.Remotely accessing the dc server, the rse was not able to locate ptty\filezilla for remoting into the hemo apps station 10.138.131.232.The system was rebooted but remained down for approximately three minutes.The product remains at the customer site.Due to the lack of available information, a malfunction of the device cannot be ruled out.There is no indication that this failure could be difficult to detect.Additionally, the available information from this report does not support that this failure represents a systemic, design, or labeling problem.Further information has been requested.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The customer confirmed the unit's freezing of screen was not responsible for the patient coding and there was no lack of awareness to the patient's condition.The patient continued to be appropriately resuscitated; the patient survived.Despite the system failure, the patient continued to receive appropriate advance cardiac life support (acls).A philips remote service engineer (rse) interviewed the customer to evaluate the device in question.The rse provided the customer with the fc2010 preventive xper instruction for use (ifu) documentation to the customer to review for preventive maintenance work.The rse recommended, if possible, to power drain the fc2010 to restart the fc2010\hemo application station daily, or monday mornings, before each case.The rse was not able to figure out the cause of the fc2010 failure.The rse checked the hemo application wks remotely to oversee the local database size and to reconfigure it if needed.Remoting into dc server, the rse was not able to locate ptty\filezilla for remoting into the hemo apps station 10.138.131.232.(b)(6) 2023.The customer provided device logs for further review.The provided logs were forwarded to philips product service engineer (pse) for review.Pse interpretation below: "(b)(6) 2023 case (b)(4) was begun about 10:10 am they began performing a complex pci (percutaneous coronary intervention), and around 11:24 a 200-joule shock was delivered (ecg sample at that time shows course ventricular fibrillation).Treatment continues, with intermittent v fib and additional shocks, 41 in total all documented as 200.At 11:30 the patient is intubated, and vital signs are taken over by anesthesia.The last vitals signs capture from flex cardio is documented at 11:30:59 nothing specific was documented regarding the performance of the fc2010, but resuscitation and pci efforts continue.At 11:52:17 shock 14 of 41 is delivered at 11:52:28 hemo app logs indicate that the connection to the fc2010 is lost.At 11:54:21 hemo app logs indicate that the connection to the fc2010 is re-established.The case continues until 14:15 when the patient is transferred out of the cathlab with a left ventricular assist device in place".According to the pse, the unit lost connection to the fc2010 at 11:52:28 then reconnected at 11:54:21.The unit was restarted either spontaneously or it was frozen and user restarted it.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.The restart of the device resolved the issue.No subsequent calls have been logged for this device/issue.

• Brand Name: XPER FLEX CARDIO 2020 REV D EXCHANGE
• Common Device Name: XPER FLEX CARDIO 2020 REV D EXCHANGE
• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16699847
• Report Number: 1051786-2023-00004
• Device Sequence Number: 3677168
• Product Code: MWI
• UDI-Device Identifier: 00884838086012
• UDI-Public: 00884838086012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• 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: 453564675001
• Device Catalogue Number: 453564675001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 87 KG