MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH CT SOMATOM SENSATION 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 7393114

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

This event is a work-related accident/ worksite incident and is deemed to be an error on the part of internal service personnel.Broken transport cases should not be accepted and sent back to the manufacturer as instructed per internal procedure.The concomitant device was not returned.

Event Description

It was reported that during service performance the service technician carried a heavy transport box that contained an x-ray tube for the ct system and suffered a hernia.The wheels on the transport box were not in proper working order upon receipt.The service technician is scheduled for surgery in the near future for the hernia that is due to this work-related accident.There is no malfunction of the device reported.

• Brand Name: SOMATOM SENSATION 16
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH CT; medical solutions; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH CT; medical solutions; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6499718
• MDR Text Key: 73022166
• Report Number: 2240869-2017-76386
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Service Personnel
• Device Model Number: 7393114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: X-RAY TUBE TRANSPORT CONTAINER
• Patient Outcome(s): Hospitalization; Other; Required Intervention