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

Model Number	453564243591
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during patient surgery, only the speed of the electrode was changed, and the physician had to correct it manually.The device was in use on a patient.There was no report of patient or user harm.

• 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
• MDR Report Key: 11810833
• Report Number: 1051786-2021-10017
• Device Sequence Number: 11740059
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: 00884838082113
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564243591
• Device Catalogue Number: 453564243591
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1