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

Model Number 8098027

Device Problems Loose or Intermittent Connection (1371); Mechanical Jam (2983); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is on-going and siemens will submit a supplemental report upon completion.

Event Description

The customer notified siemens on (b)(6) 2016 that a patient's femur was broken after the knee became lodged in the bore when acquiring a topogram.The knee was caught on the plexi-glass.Reportedly, the patient is paraplegic and was being scanned for a chest/abdomen/pelvis combination exam.One of the patient's legs was raised higher in the gantry however straps were used to position and hold the leg.As the table moved through the gantry for the scan, the patient's knee was pushed into the plexi-ring, jamming the plexi-ring in to the gantry.The gantry made noise as it rotated and caused the front cover to become loose.There is no information as to the patient's status at this time.

Manufacturer Narrative

A thorough investigation into the reported incident has been conducted and indicates user error.The user reported that they expected an automatic stop when the paraplegic patient's knee made contact with the inner plexi-ring and became jammed.However, users are trained and the user manual gives clear instructions to observe the patient at all times, to check the traverse path and stop movement by releasing the movement button.In the case of an emergency or unwanted movements the user is trained and instructed to activate the red stop button.It is reported that the user has received further training to prevent recurrence.There have been no reports of the described problem since then.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; 1 siemensstrasse; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; medical solutions; 1 siemensstrasse; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 5620757
• MDR Text Key: 44080116
• Report Number: 2240869-2016-39037
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: 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