MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV; ACCELERATOR, LINEAR, MEDICAL

Model Number 08139789

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Abrasion (1689)

Event Date 04/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Siemens has initiated a technical investigation of the event.The gantry cover was inspected and reattached using the same screws.No breakage of any component was found.The root cause of the loosening and detachment of the gantry cover is unknown at this time.If additional information is provided, a supplemental report will be submitted.

Event Description

It was reported to siemens that the front gantry cover of the artiste system fell on the patient when the gantry moved from 180 degrees to 200 degrees.The patient suffered a moderate injury which required medical treatment with antiseptic.The patient was then scanned using ct imaging and no further injury was found.The reported event occurred in (b)(6).

• Brand Name: ARTISTE MV
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486484
• MDR Report Key: 9972014
• MDR Text Key: 191614041
• Report Number: 3002466018-2020-25883
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K072485
• 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
• Report Date: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08139789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2020
• Initial Date FDA Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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