MAUDE Adverse Event Report: PHILLIPS NORTH AMERICA LLC ECHO ULTRASOUND MACHINE PROBE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

Echo machine probe locked up twice.Machine rebooted.A xsprobe from another machine obtained and testing completed.Fda safety report id # (b)(4).

• Brand Name: ECHO ULTRASOUND MACHINE PROBE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): PHILLIPS NORTH AMERICA LLC
• MDR Report Key: 11991571
• MDR Text Key: 256449438
• Report Number: MW5101858
• Device Sequence Number: 1
• Product Code: LLZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 87 YR