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

Model Number	453564243591
Health Effect - Clinical Code	Death (1802)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.According to the customer, the patient, who presented a complete atrioventricular block (avb) leading to asystole during the implantation of tavi not corrected by the training probe that must have moved, avb seen on the screen with more than 10 seconds delaying the treatment.This avb led to asystole which required resuscitation with several recurrences of asystole hence the need for orotracheal intubation and a progression to multi-visceral failure leading to death (patient with multiple comorbidities).The customer further stated that earlier detection of avb would have potentially led to faster management and avoided progression to asystole, resuscitation, and multi-viscular failure.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
According to the customer feedback, the problem in scope was a delay of about 10 seconds between the trace on the screen and the actual rhythm of the patient was observed, which the customer believes is one of the elements that triggered the patients death.
Additional Manufacturer Narrative
H10: when this issue was initially investigated back in june, a philips field service engineer (fse) was dispatched to the customer's site.However, upon arrival, the system was in use and not made available for further testing/evaluation.This issue was reported to have only occurred once and the system has been functioning normally since a reboot was performed by the customer during the course of their troubleshooting.The fse further indicated that, after speaking with staff that, the device was almost never restarted.The customer was advised by the fse to reboot the system on a regular basis and no further repair activity was deemed necessary by the onsite engineer.The device remained in use at the customer's facility following the reported incident on (b)(6) 2020.Log files have been obtained for this case and were reviewed by a clinical product specialist 4.The two cases provided, (b)(4), are linked to the same patient.The procedure was started under patient (b)(6) , however when the problem presented itself and a reboot of the device was performed, staff then created a new patient with the same name ((b)(6) ) to continue the exam.According to mr.Hinebaugh, the first file was time stamped 10:53 and shows a sinus rhythm, and the second was time stamped 12:05 and shows a wide complex bradycardia, possibly some evidence of p waves which are not related to the r waves and may be a 3rd degree block with st elevation; we also can see an arterial.It was stated by the product specialist that it appears that the nibp (non-invasive blood pressure), spo2, or any other monitoring was not being used, and regular interval vital signs were not documented during the case.Based on the customer's feedback, a clinical assessment (ca), regulatory compliance evaluation (rce), and health hazard evaluation (hhe) was initiated for the "delay between the trace on the screen and the actual rhythm of the patient", (ref.(b)(4)).According to the hhe, based upon the available data from the field, and due to the poor overall patient¿s condition and multiple comorbidities, it is reasonable to conclude that the reported duration of delay in data display is clinically insignificant, and would not have had a direct effect on the patient¿s condition if other resuscitative measures were in place.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.H3 other text : the device was not made available for evaluation by the customer.

• 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: 10671425
• Report Number: 1051786-2020-00049
• Device Sequence Number: 3345578
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: (01)00884838082113
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564243591
• Device Catalogue Number: 453564243591
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death