MAUDE Adverse Event Report: SIEMENS S.A. MOBILETT ELARA MAX; MOBILE X-RAY SYSTEM

Model Number 11107444

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

The cover on the concerned unit was replaced.Investigation is on-going.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 an incident with the mobilett elara max system.A side cover of the mobile x-ray device fell off when the system was moved.There is no patient involvement in this case.The reported event occurred in (b)(6).

Manufacturer Narrative

Investigation showed that on some elara max systems there is unfavorable tolerance combination between the side cover and system chassis, which may adversely affect the fixation mechanism between cover and chassis.The snap locks may not lock properly, or the velcro fixation tape may mechanically overstress and lose connection.Additional fixation pins around the side cover are unable to hold the entire cover.Therefore, when during system movement, the side cover detached at the upper end producing a gap between the cover and the system.A hardware change is being developed to prevent unintentional loosening of the cover.Metal brackets will be mounted on the cover and on the chassis and then secured with a screw.This hardware solution is planned to be introduced for future production and in the installed base with update instruction xp032/19/s in december 2019.Until the corrective action is implemented, the service organization was informed with a separate notification to check the side cover fixation during service visits and attach it properly in case it is not in accordance to specifications.

• Brand Name: MOBILETT ELARA MAX
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS S.A.; parque empresarial la carpetan; avenida leonardo da vinci, 15; 28906 ; SP 28906
• MDR Report Key: 8884430
• MDR Text Key: 219479511
• Report Number: 1000342169-2019-91880
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K182639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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: 11107444
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other