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

Model Number 11107444

Device Problem Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Nerve Damage (1979)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter¿s phone number is (b)(6).Siemens healthcare checked the system and configured it for its driving behavior, since the user had stated that movement was more abrupt than with another mobilett elara max system at the same site.It was identified that there was no system malfunction.The user acknowledged the incorrect use of the system while moving it through the door.The user was informed of the relevant pages of the system user manual (pages 13 and 20) which instruct the user how to safely move the system.

Event Description

The customer stated that a user¿s foot was injured while moving the mobilett elara max system.Two users were trying to push the system through a small door, one held the door open while standing on the side of the system and the other was driving the system.It was communicated that the system started moving quite abruptly and then rolled over the foot of the user holding the door open.The event resulted in a bleeding laceration and the diagnosis of ongoing nerve damage in the user¿s foot.

• Brand Name: MOBILETT ELARA MAX
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16205233
• MDR Text Key: 307691260
• Report Number: 3004977335-2023-00008
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K182639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• 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
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability