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

Model Number 10165977

Device Problem Human-Device Interface Problem (2949)

Patient Problems Injury (2348); Suture Abrasion (2497)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens conducted a thorough investigation into the reported event and has determined that while the ct scanner operated as specified and there was no non-conformity, the mattress was found to be out of the correct position, which could expose the small opening between the table top and table.The operator's manual instructs the operator to use positioning aids (belt, arm support) that are available for proper patient positioning.The operator's manual also cautions the operator to closely monitor the patient during examination to avoid injury from system movement.Considering this, no further corrective action is initiated.Customer address: (b)(6).

Event Description

Siemens was notified on november 28, 2017 that an unconscious (b)(6) years old female patient's left thumb became trapped between the table and table top when being moved out from the gantry.It is reported that after performing a head ct scan the operator was moving the table out of the gantry when the movement was blocked.The operator checked to see what was blocking when they discovered the patient's left thumb was trapped between the table and table top.The patient's thumb was immediately bandaged and an orthopedic doctor examined and sutured the patient's wound.The patient remains hospitalized in the intensive treatment unit in relation to the initial condition.It is reported after follow-up that the patients thumb is okay.This reported event occurred in (b)(6).

• 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: 7136072
• MDR Text Key: 95451057
• Report Number: 3003202425-2017-08267
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151752
• 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: 12/20/2017,11/28/2017

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: 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: 12/20/2017
• Distributor Facility Aware Date: 11/28/2017
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2017
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2012
• 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): Other
• Patient Age: 82 YR