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

Model Number 10594738

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The multiple collision marks are not a result of regular system operation but improper use.The operator was advised by siemens not to use the concerned system in existing condition without repairs.

Event Description

Siemens service organization provided information about a mobile x-ray system - mobilett mira max - that represents risk in case of further clinical operation.The fork holding the x-ray tube assembly was found to be cracked and may potentially fall down.In addition siemens service organization found multiple visible collision marks on the machine.The user was advised not to use the unit until a respective correction is performed.There are no injuries attributed to this event.

Manufacturer Narrative

**resubmission of initial report as per fda on 04/03/2019** the investigation of the reported incident was completed with the following results.The fork and the single tank unit were returned for analysis.The single tank unit showed several collision marks; this indicates high mechanical impact on the tube assembly that led to the described damage of the fork.When driving the system the operator must avoid any collisions of the tube assembly to prevent system damage.The correct handling when moving the system is described in the operator manual (see xpr8-270.620.01.01.02 chapter "safety" page 22).The fork that holds the single tank is designed and tested to fulfill a four-fold mechanical safety.No general problem was identified.The spare part consumption of the fork shows values below the defined threshold.At the concerned customer site the issue was resolved by replacing the fork and the single tank unit.The system is fully functional.

• 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: 8524602
• MDR Text Key: 153109206
• Report Number: 3002808157-2018-59396
• 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
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 10594738
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• 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