MAUDE Adverse Event Report: SHIMADZU COPORATION RADSPEED PRO; SYSTEM, X-RAY, STATIONARY

Model Number	503-79460-41
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We will have the damaged parts replaced and returned to the factory for analysis.
Event or Problem Description
During use, the x-ray tube support section of the ceiling type x-ray tube support came off the x-ray tube support pull-up section, and the technician supported the x-ray tube support section and lowered it to the floor.The patient was not injured.We have received reports that had strained shoulder when the technician lowered the x-ray tube support section to the floor.
Additional Manufacturer Narrative
Based on the hearing information from the site and the analysis results of the parts collected, the cause of the current incident can be estimated as follows.The repeated rotation of the x-ray tube support section, which caused it to hit the mechanical stopper more violently than expected, resulted in the loosening of the fixing bolt.It is highly probable that the fixing bolt failed due to fatigue because the fixing bolt continued to be used in a loose state.Before the occurrence of this incident, the mechanical stopper of the x-ray tube support section had also broken.It is inferred that a considerable amount of load was applied to the fixing bolts even in the process leading to the breakage of the mechanical stopper.Eight fixing bolts are unlikely to break simultaneously.It is thought that the bolts that receive the most impact force when rotating around the vertical axis of the x-ray tube support section are broken in order.It is probable that after all the bolts broke, it became possible to perform rotation of x-ray tube support around the vertical axis without releasing the brake, and the user performed rotation around the vertical axis without releasing the brake.The operation manual requires confirmation that the rotation of the x-ray tube support section is locked during the daily inspection, and we believe that it is possible to notice that the bolt is broken.If the inspection and repair had been carried out properly at that time, it is probable that the x-ray tube support section would not have come off from the x-ray tube support pull-up section as it did in this case.It is considered highly unlikely that the x-ray tube support section will come off as shown in the above.On the other hand, when the maintenance is not carried out properly, as in this case, it is undeniable that the x-ray tube support section will come off, so we will implement countermeasures.
Event or Problem Description
During use, the x-ray tube support section of the ceiling type x-ray tube support came off the x-ray tube support pull-up section, and the technician supported the x-ray tube support section and lowered it to the floor.The patient was not injured.We have received reports that had strained shoulder when the technician lowered the x-ray tube support section to the floor.

• Brand Name: RADSPEED PRO
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SHIMADZU COPORATION; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485 11; JA 6048511
• Manufacturer (Section G): SHIMADZU COPORATION; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485 11; JA 6048511
• Manufacturer Contact: takeshi yamamoto ; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485-11 ; JA 6048511
• MDR Report Key: 15902781
• Report Number: 8030233-2022-00002
• Device Sequence Number: 12074740
• Product Code: KPR
• UDI-Device Identifier: 04540217052479
• UDI-Public: (01)04540217052479(11)1808008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 503-79460-41
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8030233-04/10/23-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown