MAUDE Adverse Event Report: SIEMENS AG MEDICAL SOLUTIONS SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8098027

Device Problem Material Integrity Problem (2978)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 03/02/2015

Event Type  Injury  

Event Description

Siemens was informed on (b)(4) 2015 that when the customer was carrying the phantom the screws became loose and it fell apart.Reportedly, the phantom fell on the technician's leg leaving a small scratch and a bruise.There is no other information available and the status of the technician is unk at this time.

Manufacturer Narrative

Siemens became aware of the reported incident on (b)(4) 2015.This mdr is being mailed on (b)(4) 2015.The investigation is on-going and a supplemental report will be submitted upon completion.

Manufacturer Narrative

Siemens received the part from the customer and conducted a thorough investigation.The housing/body parts of the phantom are not broken or damaged.The screws for keeping the phantom parts together are broken.The root cause for the broken screws is not clear however based on the available information it has been concluded that the reported incident is not based on a design or material problem of the phantom.It was most likely caused by careless handling of the user.This reported incident has been classified as a single case and considering this, no corrective action is initiated.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS AG MEDICAL SOLUTIONS
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS
• Manufacturer Contact: marilynne galloway ; 51 valley stream pkwy.; ms -d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 4643608
• MDR Text Key: 5600075
• Report Number: 2240869-2015-07702
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• 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?: Yes
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other