MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION NOBLUS

Model Number UN0550

Device Problems Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Hitachi received a complaint from the customer site regarding the noblus (un0550) ultrasound system on (b)(6) 2021.The site reported that the system booted up and was able to scan but then the image froze.The site was not able to unfreeze the image.The patient was under anesthesia during the troubleshooting process.The staff was unable to unfreeze the image so the prostate biopsy procedure was aborted/cancelled.Hitachi qa/ra team followed up with the site and confirmed the patient is unharmed.The procedure was rescheduled for another day.Hitachi service dispatched an engineer to the site to remove un0550 and replaced it with a functional system.Un0550 returned to hitachi us lab for troubleshooting.Hitachi us lab evaluated the system but was unable to identify root cause.Hitachi us lab replaced the backend board, cpu, and cellboard pcb.The us lab also reloaded software and customer presets.The us lab confirmed no freeze up occurred after troubleshooting measures, thorough testing, and qa check were performed.The manufacturer has been notified and a formal complaint was opened.The site did not provide patient information.The only patient identifier hitachi received was patient gender.

Event Description

On (b)(6) 2021 hitachi received report of an aborted procedure.The site was using the noblus ultrasound.

Manufacturer Narrative

On august 02, 2021, root cause investigation was concluded.Details of investigations are as follows: the replaced parts were investigated.It was suspected that the system memory of the cell board failed, and it was determined that this was a random component failure that did not require remedial action.During a retrospective review, it was discovered that the investigation was ongoing at the time of the initial mdr, and the investigation results had not been reported to fda.As such, a supplemental mdr is being submitted at this time.

• Brand Name: NOBLUS
• Type of Device: NOBLUS
• Manufacturer (Section D): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): FUJIFILM HEALTHCARE CORPORATION; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: kan tsushima ; 2-1 shintoyofuta; kashiwa-shi; chiba-ken,, OH 277-0-804 ; JA 277-0804 ; 3304251313
• MDR Report Key: 11390887
• MDR Text Key: 240082278
• Report Number: 8030405-2021-00003
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UN0550
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male