MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD AXIOM ARISTOS VX PLUS; STATIONARY X-RAY SYSTEM

Model Number 10272410

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

The trolley um patient table for the axiom aristos vx plus was designed and verified according to iec 60601-1, including the stability test in normal use, which was passed successfully.In the operator manual for the um patient table it is stated for the operator to "move the table to an appropriate position, lock both castors and ensure the table is fixed".In cases when patients are leaving the table, the operator is advised to "lock both castors and help the patient from the table".The concerned um patient table was inspected by siemens local service.No defects of wheel brakes were found; both castors can be locked by the brakes according to specs.However, a feedback was received that the operator was not sure whether the 2 brakers had been locked firmly during the operation.It is assumed that the reported event occurred due to user error.Internal id# (b)(4).

Event Description

Siemens became aware of an event that occurred on theaxiom aristos vx plus unit.During a service call siemens local service engieer was infromed of an incident with a patient.When the patient was getting off the trolley um patient table following leg examination, due to the trolley um patient table not being stable, the patient fell to the ground.This resulted in patient's hip bone being broken.The injury resulted in medical treatment.The reported incident occurred in (b)(6).

Manufacturer Narrative

Siemens is submitting correction to section g4 of the initial and follow-up medwatch report # 3004754211-2021-72374.A clerical error was made in section g4 and "combination product" was checked by mistake.

Manufacturer Narrative

Siemens is filing a supplement to the initial medwatch report # 3004754211-2021-72374 to correct 510k # provided in the original submission.Initially provided 510k k013826 is incorrect; the correct 510k is k983732.

• Brand Name: AXIOM ARISTOS VX PLUS
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD; 278 zhou zhu road; shanghai 20131 8; CH 201318
• MDR Report Key: 11628747
• MDR Text Key: 244381228
• Report Number: 3004754211-2021-72374
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K013826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10272410
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR