MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH NAEOTOM ALPHA; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11330003
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the naeotom alpha ct system.A 60-69-year-old female patient was planned for two scans (head and thorax/abdomen).The patient was positioned with feet first and was instructed by the operator to have both arms crossed over the body.After the head scan, without the knowledge of the operator, the patient lowered her arms to the sides of the body.During positioning of the second scan, the patient¿s finger was pinched between the tabletop and its cover.As a result, the patient suffered an abrasion to the finger.The patient was treated with minor first aid and no further medical intervention was necessary.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.An evaluation of the system revealed that the gap dimensions of the patient table have been investigated and found within specification.According to the owner¿s manual (instructions for use), it is recommended to place patient's arms on their body and to use positioning aids when necessary and to observe the patient during all system movements and to press the stop key in urgent situations.Based on available information the system worked as specified.No further measures are deemed to be necessary.

• Brand Name: NAEOTOM ALPHA
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17497614
• Report Number: 3004977335-2023-00086
• Device Sequence Number: 2394467
• Product Code: JAK
• UDI-Device Identifier: 04056869263168
• UDI-Public: 04056869263168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11330003
• Device Catalogue Number: 11330003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female