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

Model Number 10594738

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The multiple collision marks are not a result of regular system operation but improper use.Regular inspection or the daily checks should result in service involvement to initiate respective correction.The overall condition of the x-ray tube assembly should prevent operator from further system use in current condition without repairs.A supplemental report will be submitted if additional information becomes available.Internal id: (b)(4).

Event Description

Siemens was informed by its service organization about potential risk with the mobilett mira max system.The fork holding the x-ray tube assembly is cracked and may fall.Multiple collision marks are visible.There is no patient involvement in this case and no injuries are attributed to this event.

• Brand Name: MOBILETT MIRA MAX
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 9116355
• MDR Text Key: 188869071
• Report Number: 3002808157-2019-99314
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10594738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 09/25/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other