MAUDE Adverse Event Report: FUJIFILM CORPORATION FDR ACSELERATE; SOLID STATE X-RAY IMAGER

Model Number DR-XD200

Device Problems Fire (1245); Smoking (1585)

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

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

There are no reports of similar problems from other facilities.The device will be investigated.If any additional relevant information becomes available, a supplemental report will be submitted.

Event Description

On 07/08/2021, fujifilm corporation was informed of an event involving the dr-xd200 x-ray system.Customers were using the system till 4 am and later it was in idle state, at around 5 am customers noticed smoke and flame coming out from the x-ray generator.Customer switched off the mains power but the flames increased in some time.Finally the fire department people came and they controlled the fire and later the generator was disconnected by cutting all the system cables.There was no patient impact, serious injury or death associated with this event.This report is being submitted in abundance of caution.

Manufacturer Narrative

On 05/10/2022, fujifilm concluded that this incident may have been caused by external factors.The root cause of the failure could not be clearly identified.There were no device related factors identified during the investigation, and as such, it is assumed that an external event triggered a short-circuit underneath the motherboard.It was observed that the external system breaker on the distribution line failed to disconnect the input line of the generator to stop the damage thereby leading to increased impedance.Flammable contamination was also observed near the vicinity of the motherboard.However, neither of these factors could be confirmed as the root cause.

• Brand Name: FDR ACSELERATE
• Type of Device: SOLID STATE X-RAY IMAGER
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: safety officer ; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 12239454
• MDR Text Key: 265990078
• Report Number: 3001722928-2021-00017
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR-XD200
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1