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

Model Number	453564667151
Medical Device Problem Codes	No Display/Image (1183); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported failures of the measurement.The values are not displayed.
Event or Problem Description
The customer reported failures of the measurement.The values are not displayed.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
The complaint was reported conservatively based on the information available at the time the reporting decision was made.Additional information has now been obtained that indicates that the customer did not experience the problem as described in the fieldchangeorder (fco) and that the customer only had questions about the fco implementation to ensure that implementation of the fco aligns with the facility¿s maintenance schedule.H3 other text : the customer did not experience a device problem.The customer only had questions related to the device.

• 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: 11826202
• Report Number: 1051786-2021-10019
• Device Sequence Number: 1059283
• Product Code: MWI
• UDI-Device Identifier: 00884838083820
• UDI-Public: 00884838083820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup

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: 453564667151
• Device Catalogue Number: 453564667151
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/04/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1