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U.S. Department of Health and Human Services

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

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HITACHI, LTD. HITACHI PROSOUND F75 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
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.
 
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Brand NameHITACHI PROSOUND F75
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
HITACHI, LTD.
1959 summit commerce park
twinsburg OH 44087
MDR Report Key13860190
MDR Text Key287673295
Report Number13860190
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPROSOUND 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 FDA03/15/2022
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer03/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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