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

Model Number	453564634201
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Application Program Problem (2880)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the patient went into asystole during a pacemaker cauterizing case where the ekg read flat lines.
Additional Manufacturer Narrative
According to the customer, the patient was stable coming into the room but went into asystole and came out on its own.Right before this happened using the cauterizing tool megadine 0035h, all ekg went flat line and the customer rebooted 5 times before it came back up to show ekg.Patient was stable upon leaving room.Customer is requesting service to look and test unit as this has made the doctor very uneasy.It was also discovered that the flex versions do not match, the host is on 1.5.17.034 but the front end is on 1.5.19.A follow-up report will be submitted upon completion of the investigation.
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 service notes, the fse tested the system and was unable to reproduce the customer's reported problem.The fse reimaged the device and again tested the unit.The device passed all functional testing.However, a replacement device was ordered for customer assurance.A search in salesforce found one additional case, salesforce case (b)(4) , from 10-jan-2022, in which the customer reported intermittent nibp (non-invasive blood pressure) issues as well as issues with the loss of ecg when esu tools are used.A fse visited the customer's site and tested the equipment with his simulator but could not duplicate the reported issue.The fse reimaged the fc2010 device, purged case data, performed database updates, and disabled the power management in the fc2010 device.The fse verified device operations and returned the equipment to the user.The absence of further calls supports that the reported problem has not reoccurred or was resolved.
Event or Problem Description
The customer reported that the patient went into asystole during an outpatient pacemaker implant case.

• 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: 13168645
• Report Number: 1051786-2022-00002
• Device Sequence Number: 5422661
• Product Code: MWI
• UDI-Device Identifier: 00884838084902
• UDI-Public: 00884838084902
• 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,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?: Yes
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2017
• 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: Other
• Patient Sex: Unknown