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

Model Number	11020896
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware on an incident with the multix impact c unit.The user's finger was cut by a sharp edge or corner when pulling out the tray of the bucky wall stand (bws).No medical intervention was required.
Additional Manufacturer Narrative
According to the provided picture, the distance between the bws and the room wall was not sufficient, causing the user's hand to be cut on one of the metal pieces of the bws while pulling out the tray.According to the current investigation, it is assumed that the bws was incorrectly installed.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Additional Manufacturer Narrative
H10 manufacturer narrative: in response to this complaint, siemens shanghai has completed additional training of the siemens staff member and installation engineer involved in the reported event to ensure an incorrect order and installation do not recur.The complaint has been closed.
Additional Manufacturer Narrative
The complaint issue was investigated in detail.Additional clarification was also obtained during the investigation.Based on clarification by the siemens customer service engineer (cse) the problem was caused by incorrect installation of the bucky tray.The tray was too close to the wall and could not be pulled out completely.The installation order and installation itself did not follow the room layout drawing and it was difficult for the technician to insert the detector.Because of this, the technician's finger was squeezed and the skin pinched resulting in a cut.The cut was cleaned, and a bandage was applied.Additional medical intervention was not necessary for this injury which was not assessed as serious.After the investigation it was concluded the hand grip and the system designed and performance are within specification.The root cause of the issue is attributed to the installation order and installation not adhering to the room layout drawing dimensions.The room layout drawing shows that the site planned to have a right bucky configuration; however, the incorrect bucky was ordered (left configuration) and installed.Additional training is being planned for the ordering staff member and the installation engineer to ensure an incorrect order and installation do not occur again.B2: hospitalization (initial or prolonged) and other serious or important medical events should not have been checked in initial report submitted to the fda on october 31, 2022.G2: report source health professional should have been checked in the initial report.H1: type of reportable event - product problem should have been checked instead of serious injury in the initial report.

• 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): REBECCA.TUDOR@SIEMENS-HEALTHINEERS.COM; 278 zhou zhu road; shanghai, 20131 8; CH 201318
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15698338
• Report Number: 3003202425-2022-47787
• Device Sequence Number: 8221146
• Product Code: KPR
• UDI-Device Identifier: 04056869262147
• UDI-Public: 04056869262147
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2023

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
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 03/27/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/16/2023; 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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; Hospitalization
• Patient Sex: Unknown