MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS XPERIM HARDWARE

Model Number	860335
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Application Program Problem (2880)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the monitoring screen went blank after shocking the patient.
Event or Problem Description
The customer reported that the monitoring screen went blank after shocking (defibrillating) a patient.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
Subsequent information received from the customer indicated that, the procedure being performed was a tee/cardioversion (transesophageal echocardiogram (tee) with cardioversion) done in pre/post room 4 on (b)(6) 2021.For this case, end users had "split" the screen, with charting on one half of the screen and hemo (monitoring) on the other.According to the customer, there was no patient harm, but the patient was sedated, and there was a delay in monitoring while the device was rebooted.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 the fse, he was unable to confirm the customer's reported problem during his evaluation.The device passed all functional testing and was returned to service.A search in salesforce found no further related calls.We are considering this to be a malfunction of cause unknown.The device remains in use 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.

• Brand Name: XPERIM HARDWARE
• Common Device Name: XPERIM HARDWARE
• 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: 12753672
• Report Number: 1218950-2021-11070
• Device Sequence Number: 1442616
• Product Code: MHX
• UDI-Device Identifier: 00884838084919
• UDI-Public: 00884838084919
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• 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: 860335
• Device Catalogue Number: 860335
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 97 KG