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

Model Number 8098027

Device Problem Human-Device Interface Problem (2949)

Patient Problem Fracture, Arm (2351)

Event Date 10/14/2017

Event Type  Injury  

Manufacturer Narrative

Siemens has deemed the reported event as use error as the patient was not fixed with straps / belts as recommended in the user manual.Considering this, no corrective action is initiated.

Event Description

Siemens was notified on november 9, 2017 that a patient's arm was re-injured during unloading after a ct scan on (b)(6) 2017.It is reported that the patient had two existing fractures of the humerus in their left arm that was surgically treated with internal fixation and prescribed an external splint prior to being scanned.After the scan, the doctor moved the table out from the gantry to unload the patient.The patient's left hand was located under the table at the time of the table movement and became stuck between the table and gantry, resulting in the patient's arm being re-injured.It is reported that there was no use of straps to secure the patient prior to scanning.The patient was treated in the hospital however there is no information available as to the patient's status at this time.This reported event 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: 7068924
• MDR Text Key: 93286313
• Report Number: 3004977335-2017-04469
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2017,11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• 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: 11/30/2017
• Distributor Facility Aware Date: 11/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2017
• Date Manufacturer Received: 11/09/2017
• 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: 64 YR