MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT SOMATOM DEFINITION FLASH; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10430603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Loss of Range of Motion (2032)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further investigations are planned as country-specific work instructions are in place and are to be followed.The general safety notes for service state in chapter 4.9, working with heavy loads: in addition to wearing the required protective gear, e.G., safety shoes and gloves, ensure that heavy loads are lifted and carried properly to prevent physical injury (e.G., to the spine).Heavy or awkward loads should be moved using technical aids or by more than one person.The relevant information must be observed.According to the information available, the somatom definition flash ct system neither caused or contributed to the injury.However, due to the nature of the reported injury, this report has been submitted with an abundance of caution.
Event or Problem Description
It was reported that an adverse event occurred while performing maintenance activities associated with a somatom definition flash ct system.A siemens engineer injured himself while lifting a crate containing a spare part (slip ring) together with two colleagues on (b)(6) 2022.The service engineer stated that his elbow cracked several times and he lost strength in his arm.The engineer also reported pain and bruising.An x-ray and mri examination were ordered for the service engineer.The x-ray examination was performed.Further information on the extent of the injury has been requested but are not known at the time of reporting.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15851373
• Report Number: 3004977335-2022-51064
• Device Sequence Number: 5216454
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown