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

Model Number	453564243591
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the boom hemo waveforms are freezing.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: 11896691
• Report Number: 1051786-2021-10024
• Device Sequence Number: 3685384
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: 00884838082113
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: 05/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1