MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MOBILETT MIRA; MOBILE X-RAY SYSTEM

Model Number 10273100

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/19.Siemens engineer visited the facility and fixed the issues with the screws.A supplemental report will submitted if additional information becomes available.Customer's address: (b)(6).

Event Description

It was reported that during a patient examination on mobilett mira the user was holding the collimator when it dropped down.Siemens engineer visited the site and found loosened screws on the tube hinges.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided pictures showed that the fixation screws for the collimator were not attached per specifications.The single tank is always delivered with four screws of m4 x 25, loctite and washers.The investigation indicates that no original screws were used to fix the collimator hinge.The damaged red lead cone shows that it was manipulated while trying to remove it.A service intervention was performed on this system prior to this event to replace the collimator lamp switch.During this intervention status of these fixing screws should have been noted.It was verified that only trained service technicians performed work on this system.The document for replacement of parts was checked and the information how to re-apply the screws in case they need to be removed is already documented (xpr8-260.841.01.09.02 - page 271).The concerned unit was repaired by using correct screws.Furthermore, the single tank and the collimator were replaced.The spare part consumption of both components was checked and shows normal values that are below the defined threshold.This report was submitted january 16, 2018.

• Brand Name: MOBILETT MIRA
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 7196027
• MDR Text Key: 142795203
• Report Number: 3002808157-2017-85920
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K111912
• 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: 06/27/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: 10273100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 12/04/2017
• Supplement Dates FDA Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other