MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT, LTD. SOMATOM EMOTION 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 10165977

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate User Interface (2958)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 07/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation shows that the gap between table top and the top support is 6~7.8mm, less than 8mm, which fulfills the iec requirement.Warning labels are applied on the front end of the table near the gap and positioning aids are present.The operator's manual cautions the user to verify that the patient is correctly positioned and to always observe the patient during system movements.There is also a stop key that is to be pressed in urgent situations.This is the first case of approximately 8,000 systems.Therefore, this is considered to be a single case and no further corrective action is initiated.

Event Description

Siemens was notified on (b)(6) 2017 that a patient's forefinger was fractured with laceration when it became stuck between the table top and table frame while the patient table was being unloaded after a head and thorax examination was completed.It is reported that the patient's left hand is paralyzed.The doctor took precautions to position both of the patients arms on the table, parallel on both sides of the patient's body prior to examination.After examination, the doctor unloaded the patient from the gantry by pressing the "move" button on the control box in the control room.The patient's injury was discovered when the accompanying person went into the examination room.An x-ray of the patient's finger showed that it was fractured.The patient received medical treatment.This reported issue occurred in (b)(6).

Manufacturer Narrative

Further investigation showed that the front cover of the ct system was damaged possibly due to daily use and collision.The damage caused the frame to be deformed and the cover could not be installed in the right position.This made the gap between the table top and the metal frame larger than 8mm and also made the gap between the table top and the front end cover larger than 8mm.The cover has been replaced and the gap has been reduced to less than 8mm, which is in specification.

• Brand Name: SOMATOM EMOTION 16
• 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: 6786094
• MDR Text Key: 82459142
• Report Number: 3003202425-2017-88135
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2017,07/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 10165977
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2017
• Distributor Facility Aware Date: 07/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2017
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2010
• 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: 88 YR