MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD MULTIX FUSION; STATIONARY X-RAY SYSTEM

Model Number 10746666

Device Problem Use of Device Problem (1670)

Patient Problem Hematoma (1884)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

The multix fusion unit is designed with the dmg (deadman grip) function; motorized movements are only activated when a control element is activated to continue.All system movement will be stopped if the control element is released.In the reported event, the operator released the switch, and the table movement was blocked preventing any injury to the patient.The described behavior proves that the dmg function is within specifications, and this safety measure is effective.Additionally, the unit is equipped with red stop emergency button to prevent all system movement as well as tabletop collision detection sensors.The operator manual mentions dangers of crushing or collision for persons when lowering the patient table, and advises operators to pay attention to unit movements and danger zones.The concerned unit was checked by local siemens service engineer.The machine was found to be within specifications.Internal id # (b)(4).

Event Description

Siemens became aware of an incident that occurred on the multix fusion x-ray machine.During a patient exam, the operator drove the table down on to a patient leg.All device movements stopped after the collision.A small red bruise on top of the patient's knee was reported.The patient was referred to ortho specialist, however, no x-rays were required.

• Brand Name: MULTIX FUSION
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD; 278 zhou zhu road; shaghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu road; shanghai, 20131 8; CH 201318
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 10867990
• MDR Text Key: 217121617
• Report Number: 3004754211-2020-53789
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10746666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other