MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD. SOMATOM PERSPECTIVE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10495568

Device Problem Human-Device Interface Problem (2949)

Patient Problem Fracture, Arm (2351)

Event Date 09/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens conducted a thorough investigation that has concluded that the patient's arms were not fixed with the belt accessory during examination and the operator did not observe the patient during table movement.The operator's manual instructs the user to use the accessories (arm support, belt) that provides a secure positioning and fixation/immobilization of the patient.The operator's manual also cautions the operator to verify the patient is correctly positioned and always observe the patient during system movements, pressing the stop button in any hazardous situation.Considering this, no further corrective action is initiated.Customer address: (b)(6).

Event Description

Siemens was notified on november 24, 2017 that a (b)(6) years old, female patient that was unconsciousness during a thorax examination on (b)(6) 2017 experienced a fracture to the right humerus and ecclisis.It was reported that after examination, the customer unloaded the patient from the control box in the operating room and noticed that the patient's right arm had fallen down from the table and the arm was jammed.The customer immediately pressed the stop button, went to the patient and did not find anything abnormal about the patient's skin.However, during the patient's checkup on (b)(6) 2017, the patient's right humerus and ecclisis were found to be fractured.After treatment at the hospital, the patient was discharged.There is no further information regarding the patient's status.This reported event occurred in (b)(6).

• Brand Name: SOMATOM PERSPECTIVE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD.; 278 zhou zhou road; shanghai, 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD.; 278 zhou zhou road; shanghai, 20131 8; CH 201318
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 7133456
• MDR Text Key: 95375152
• Report Number: 3003202425-2017-06616
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/19/2017,11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10495568
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2017
• Distributor Facility Aware Date: 11/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2017
• Date Manufacturer Received: 11/24/2017
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR