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

Model Number 8098027

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Fracture, Arm (2351)

Event Date 10/29/2017

Event Type  Injury  

Manufacturer Narrative

Siemens conducted a thorough investigation of the reported incident and it has been concluded that the root cause of the incident is use error as the patient was not fixed and monitored as recommended.Considering this, no corrective action is initiated.

Event Description

Siemens was informed on (b)(6) 2017 of an incident where a patient's right arm was broken during a ct lung scan.It is reported that the patient was on the table for a lung scan and the table was moved through the gantry with the patient positioned head first.The upper portion of the patient's torso had reach the outside of the other side of the gantry.The patient's right arm was hanging off of the right side of the table when the table was moving back through the gantry and the patient's arm became clamped between the table top and the gantry.An x-ray examination showed that the patient's right humerus was fractured in two places.The patient is under treatment in the same hospital facility.This reported incident occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; siemens strasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; siemens strasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 7022303
• MDR Text Key: 91772100
• Report Number: 3004977335-2017-02961
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 11/10/2017,10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2017
• Distributor Facility Aware Date: 10/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2017
• Date Manufacturer Received: 10/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR