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

Model Number 10431700

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation revealed that the part which fell off is a flexible plastic cover with a weight of 250 grams.The size and weight of this part could lead to a minor injury in worst case.We are not aware of any similar cases.Therefore, this event is rated as a single case and this report is filed with an abundance of caution.

Event Description

It was reported to siemens that a malfunction occurred while operating the somatom drive ct system.On (b)(6) 2024, an incident occurred in which a part of the cover of the sealing mounted screen holder fell off and onto the patient's head.There is no report of impact to the state of health of the patient involved and no medical treatment was necessary.

• Brand Name: SOMATOM DRIVE
• Type of Device: 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: 18710098
• MDR Text Key: 335444652
• Report Number: 3004977335-2024-00018
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K230421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10431700
• Device Catalogue Number: 10431700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1