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

Model Number	08098027
Medical Device Problem Codes	Failure to Analyze Signal (1539); Device Sensing Problem (2917)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The system shut down was caused by an error of the phs (patient handling system - patient table) regarding table initiation and incorrect speed of the tabletop.The error was corrected by a siemens service engineer onsite.After the correction, the system is operating according to specifications.The footrest used is designed for a maximum load of 500n (500 newtons; converts to approximately 112 lbs.).The patient weight is way above the load limit, which caused the footrest to break.As a result, the patient scratched his back along the edge of the footrest mounting.The patient was evaluated in the emergency room and according to information provided, no further intervention was needed.Additionally, siemens is not aware of any further negative health consequences to the patient.In case of emergency or system shut down, the patient table should be moved out by using the emergency release according to the system instructions for use.(print no.Hc-c2-029.621.07.01.02, page 291, chapter 4.4.4).In this case, the patient himself decided to climb out of the system without waiting for medical staff to safely remove the patient from the gantry.
Event or Problem Description
It was reported to siemens that a malfunction an adverse event occurred while operating the somatom definition as ct system.A 58-year-old male patient, weighing approximately 300 lbs, was positioned on the ct table feet-first.During the scan, the system shut down while the patient was positioned in the gantry.It was reported that the patient crawled out of the gantry and off the table by himself.While crawling towards the table end, the footrest broke off the table and the patient fell while scratching his back on the broken part of the footrest.The patient was evaluated in the emergency room and no further medical care was required.

• Brand Name: SOMATOM DEFINITION AS
• 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: 16313317
• Report Number: 3004977335-2023-59264
• Device Sequence Number: 5759430
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08098027
• 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: 01/10/2023
• Initial Report FDA Received Date: 02/07/2023
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 136 KG