MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPER FLEX CARDIO 2010 REV-C-EXCHANGE

Model Number	453564621791
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the patient was declining during case and was defibrillated, which in turn caused the ekg to flat line and pressures to disappear.We are in the process of gathering additional information regarding this incident.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
H1- after further investigation it was determined there was no serious injury and downgraded to a product problem.The customer stated that after the patient was defibrillated, the ecg trace on the xims system flat lined, however the patient was in normal sinus (due to being able to see the ecg on the life pak).
Event or Problem Description
The customer reported that a patient was declining during a procedure and had to be defibrillated.According to the customer, this caused the ekg to flat line and pressures to disappear.It was reported by the customer that the patient was in poor condition and was defibrillated as a result of their condition/procedure.The customer stated that staff had to reboot the system to resume monitoring, which they feel is a safety issue.Subsequent information received from the customer indicated that, it was not so much that patient care was delayed, it was that it was more of a safety issue as staff had no way to monitor the ecg through the xims system.The customer further stated that thankfully the patient was connected to a life pak defibrillator so they were able to see the patients ecg via the small screen.The customer stated that after the patient was defibrillated, the ecg trace on the xims system flat lined, however the patient was in normal sinus (due to being able to see the ecg on the life pak).Staff was only able to get the ecg tracing back on the xims system after rebooting the "football".According to the customer, their main concern was that if the patient had gone into vt (ventricular tachycardia) for a second time, they would be unable to see it on the xims system.There was no patient impact / injury reported by the customer as a result of this incident.

• Brand Name: XPER FLEX CARDIO 2010 REV-C-EXCHANGE
• Common Device Name: XPER FLEX CARDIO 2010 REV-C-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: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13892896
• Report Number: 1051786-2022-00022
• Device Sequence Number: 6357106
• Product Code: MWI
• UDI-Device Identifier: 00884838084926
• UDI-Public: 00884838084926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: CA
• 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: Foreign,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: 453564621791
• Device Catalogue Number: 453564621791
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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: Hospitalization
• Patient Sex: Unknown