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

Model Number	453564667151
Medical Device Problem Codes	Measurement System Incompatibility (2982); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	Shock (2072); Insufficient Information (4580)
Date of Event	06/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported monitoring disruptions during defibrillation.We are in the process of obtaining additional information from the customer regarding patient involvement.
Event or Problem Description
The customer reported monitoring disruptions during cautery use and defibrillation.During an angiogram of the coronaries with angioplasty and stenting, the patient went into ventricular fibrillation (v-fib) and had to be defibrillated twice.The flex cardio device was in-use during the time of the incident during the first defibrillated shock, the flex cardio stopped working.The customer indicated they rebooted the flex cardio to resolve the issue.A philips field service engineer (fse) went to the customer site and was unable to confirm the flex cardio failure as reported, therefore we are considering this to be a malfunction of cause unknown.The device passed all functional testing and was returned to service.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15095641
• Report Number: 1051786-2022-00038
• Device Sequence Number: 20182116
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: 00884838083820
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564667151
• Device Catalogue Number: 453564667151
• 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: 06/25/2022
• Supplement Date Received by Manufacturer: 06/25/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 82 KG