MAUDE Adverse Event Report: FUJIFILM HEALTHCARE CORPORATION ARIETTA 850

Model Number U8AR0384

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

Patient Problem Insufficient Information (4580)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

Hitachi received a complaint from the customer site regarding the arietta 850 (u8ar0394) ultrasound system on (b)(6) 2021.The site reported that the system booted up and was able to scan but they lost the main image.The ultrasound system went dark.This incident occured while the patient was under anesthesia.The site was using another manufacturer's probe, an olympus linear probe uct180.The site was unable to get an image using a new maj cable and the procedure was aborted.Hitachi service dispatched an engineer to the site to evaluate the system and the probe.The site reported that they were receiving "invalid probe" error with the olympus linear probe uct180 sn: (b)(4) for a few days prior to the incident.Hitachi engineer first tested a radial probe with the us systen.The system booted up properly and operated without error.Hitachi engineer then tested the linear probe that failed during the procedure (sn: (b)(4)).The us system consistently displayed "invalid probe" error.Hitachi engineer used a different linear probe and rebooted the system.The system operated as intended.Hitachi engineer then reinstalled linear probe sn: (b)(4) and again, it consistently failed on each reboot with "invalid probe" error.Hitachi engineer advised the site to remove sn (b)(4) from service and to contact the manufacturer.The site did not provide information regarding the type of procedure or patient information.Hitachi provided the site with an incident form while on site for troubleshooting.Hitachi contacted the site multiple times but site did not complete the incident form nor provide any information, including an update on the status of the patient.

Event Description

On (b)(6) 2021 hitachi received report of an aborted procedure.The site was using the arietta 850 ultrasound with olympus probes.

Manufacturer Narrative

On march 22, 2021, root cause investigation was concluded.The investigation concluded that there was no issue with the arietta 850 ultrasound system.It is likely that the incident occurred due to a faulty probe.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: ARIETTA 850
• Type of Device: ARIETTA 850
• 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: 11518743
• MDR Text Key: 245427966
• Report Number: 8030405-2021-00004
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183456
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: U8AR0384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2020
• 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: Prefer Not To Disclose