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

Model Number	453564241901
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the sweep speed changing automatically during procedure.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: 11782593
• Report Number: 1051786-2021-10016
• Device Sequence Number: 3659847
• Product Code: MWI
• UDI-Device Identifier: 00884838103610
• UDI-Public: 00884838103610
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Remedial Action: Recall
• 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: 453564241901
• Device Catalogue Number: 453564241901
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1517-2021
• Patient Sequence Number: 1