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

Model Number	11020896
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	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the operator manual, it is responsibility of the user to ensure that the patient hand grips are in correct position and do not stand in the way of the detector moving up or down.In the reported event, the operator did not swing the handgrip to the side as advised in the manual.Therefore, when the scoli exam was started, the hand grip was not in proper position, which led to the hand grip hitting the wall stand workstation and dislocating.The stretch grip was checked by siemens local service and found to be within specifications.The multix impact c system works as intended.Siemens is not aware of any similar incidents in the field.Internal id # (b)(4).
Event or Problem Description
Siemens became aware of an incident that occurred on the multix impact c device.When the x-ray technician was preparing for a scoli series examination at the wall stand, he neither removed the stretch grip nor checked whether the overhead hand grip was firmly attached to the wall stand.As the examination began, the stretch grip caught the top of the multi purpose ortho stand causing the handle to become loose and fall forward.The part fell but missed the patient.There are no injuries attributed to this event.

• Brand Name: MULTIX IMPACT C
• Common Device Name: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD; 278 zhou zhu road; shanghai, 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: 14427378
• Report Number: 3003202425-2022-25425
• Device Sequence Number: 5488221
• Product Code: KPR
• UDI-Device Identifier: 04056869262147
• UDI-Public: 04056869262147
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: 11020896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/18/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 16 KG