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

Model Number	453564634201
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that after shocking a patient, the ecg flatlines during bovie or defib use.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that after shocking a patient, the ecg flatlines during bovie or defib use.
Additional Manufacturer Narrative
A philips field service engineer (fse) was dispatched to the customer's site to address the reported problem.According to the fse, the customer was using a spare unit upon arrival so he could not confirm the customer's reported problem.The fse reimaged the device in question and tested the unit.The device passed all functional testing and was returned to the customer for clinical use.A search in salesforce found no further related calls.The device did not behave as expected by the customer.However, onsite field service was unable to confirm the reported problem.Because of this, we are considering this to be a malfunction of cause unknown.The attending fse reimaged the device and confirmed functionality.The device remains at the customer's facility.Subsequent to the receipt of this complaint, an issue impact assessment (iia-2975-2022-511) was submitted for the issue reported.Any additional investigation or action taken will be documented in the respective record.
Event or Problem Description
The customer reported having a stemi (st-elevation myocardial infarction) case in which they had to shock the patient with a defibrillator (at approx.4:04 and 4:07am).According to the customer, right after shocking the patient, they had a flatline ecg on the boom monitor (customer is unsure if this was the same in the control room).The ecg reportedly never recovered, and the system had to be rebooted.

• 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: 12869353
• Report Number: 1051786-2021-10072
• Device Sequence Number: 17672032
• Product Code: MWI
• UDI-Device Identifier: 00884838084902
• UDI-Public: 00884838084902
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 453564634201
• Device Catalogue Number: 453564634201
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2017
• 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: Required Intervention
• Patient Sex: Unknown