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

Model Number 10594738

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going.A supplemental report will be submitted if additional information becomes available.

Event Description

Siemens received a video of uncontrolled system movement of the mobilett mira max unit.The circumstances leading to this system behavior were not described and remain unclear.A request for more information was sent to the user.The reported incident occurred in (b)(6).

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/2019.The issue was investigated in detail.It was found that the described issue was caused by two failures occurring at the same time.The analysis of the log files showed that the system displayed an error - dead man switch being stuck.During the startup phase the switch is checked by the system automatically.In case the dead man switch is activated, the handle bar is blocked to prevent any system movement.However, this error was acknowledged by the user.Additionally, according to the provided images the force sensor was not properly adjusted on the concerned system as the headless screw did not touch the gauge.The correct adjustment of these specific screws is described in the service instructions (see xpr8-270.841.01.09.02 pages 195-196).The investigation of the returned handle bar did not show any malfunction; it was not possible to reproduce the error.In case of an error event system movement can be stopped by operator at any moment by pulling the handle bar.According to information from siemens local service organization, the problem was resolved by replacing the handle bar and correct adjustment of the force sensor.In the meantime an improved revision of the handle bar is available as a spare part with increased reset force of the springs on the dead man switch.

• Brand Name: MOBILETT MIRA MAX
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8531620
• MDR Text Key: 142512854
• Report Number: 3002808157-2018-62149
• Device Sequence Number: 1
• Product Code: IZL
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10594738
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other