MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS DRF; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10762471

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/19.The system was checked by siemens local service.The system was found to be within specifications; no defects or damages were found on the footrest and no replacement was required.The pictures from the facility show that locking opening was missed by the operator and the footrest was not properly locked in.A supplement will be submitted if additional information becomes available.Customer's address: (b)(6).

Event Description

An adverse event was reported to siemens for the axiom luminos drf system.The footrest detached from the system table during an examination with a patient standing on it.This caused patient to fall down.Siemens was informed that the patient broke 3 fingers as a result of this incident.The reported incident occurred in (b)(6).

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/19.No malfunction or defect of the system or the footrest were identified.It is concluded that the footrest detached from the table due to improper installation by the user.Marks on the footrest indicate that the footrest was attached next to the locking hole.The function of the footrest was checked by siemens local service organization and no issues were identified.No part replacement was necessary.The correct attachment and use of the footrest is described in the operator manual (see xpd3-520.620.01.01.02 register 8; page 28-30).

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8524359
• MDR Text Key: 142268382
• Report Number: 3004977335-2018-52007
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10762471
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other