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Model Number 8098027 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Bone Fracture(s) (1870); Laceration(s) (1946)
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Event Date 09/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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Siemens completed the technical investigation of the reported event.The investigation confirmed the patient table gap dimensions were within tolerance.Neither a device malfunction, nor a general design issue have been identified.The root cause of the issue is user error.Per the associated system user manual, it is recommended, that the arm support should be used (user doc print no.Hc-c2-029.621.07.01.02, page 221).Further investigation within the complaint process is not deemed necessary.
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Event Description
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It was reported to siemens that a (b)(6) year-old female patient suffered abrasions and fractures to the 3rd, 4th and 5th phalanges of her left hand during a ct examination using the somatom definition as system.During table movement, the patient grabbed the system tabletop which resulted in her hand being caught between the tabletop and the table's stationary frame.The patient was positioned feet first prone on the ct table and the fixation straps were not used.The technologist confirmed a safe hand position before leaving the ct room.The patient received medical treatment for her injuries at the mercy health emergency department.Additional information regarding the event and the patient's health condition were not provided to siemens.
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Search Alerts/Recalls
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