MAUDE Adverse Event Report: HITACHI, LTD. HITACHI PROSOUND F75; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number PROSOUND F75

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The patient was undergoing an upper endoscopic ultrasound for evaluation of a suspected mass on the pancreas.The plan was to obtain biopsies and the procedure was about 90% completed when the machine shutdown.The gastrointestinal diagnostic center (gidc) staff tried to restart the machine and ce was called to inspect the machine.The team tried for 45 minutes to get the machine to turn on but it did not.They choose at that time to abort case.While in post-anesthesia care unit (pacu) the issue was disclosed to the patient and the patient referred to another hospital for completion of the biopsies.A local rep came and inspected the machine and ordered a replacement pigtail ultrasound connecter thinking that may have been the cause of machine shutdown.Gidc reported that this is not the first time that the machine has had to be inspected.Clinical engineering (ce) has been called to check out the machine for similar issues and that the pigtail connector had been checked out in the past but did not solve the problem.Pigtail connector: (b)(4) detachable cable for eus&ebus s.Manufacturer response for diagnostic ultrasound, f75 prosound (per site reporter).A local rep has been contacted to inspect the machine and came to the hospital.Identified that a pigtail ultrasound connector may be the issue and the part is on order.

• Brand Name: HITACHI PROSOUND F75
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): HITACHI, LTD.; 1959 summit commerce park; twinsburg OH 44087
• MDR Report Key: 13860190
• MDR Text Key: 287673295
• Report Number: 13860190
• 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: 03/15/2022,02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROSOUND F75
• 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: 03/15/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Race: Black Or African American