MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AMERICAS CORPORATION HITACHI ULTASONIC TRANSDUCER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number UST-9150

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

During or procedure, aloka probe device broke.The up/down mechanics does not function.The case was able to be completed by obtaining another device.The affected transducer was removed and brought to bio-med department, and we are awaiting field technician to repair device.

• Brand Name: HITACHI ULTASONIC TRANSDUCER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): FUJIFILM HEALTHCARE AMERICAS CORPORATION; 81 hartwell avenue, suite 300; lexington MA 02421
• MDR Report Key: 17208638
• MDR Text Key: 317927791
• Report Number: 17208638
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2023

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
• Device Operator: Health Professional
• Device Model Number: UST-9150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1