MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SIREMOBIL COMPACT L; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 03780629

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 06/30/2023

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.H6 component code - c-arm.

Event Description

Siemens was informed by the service organization about the incident that occurred during the service event on the siremobil compact l.During the horizontal brake replacement, the c-arm slipped off the railing and fell on the customer service engineer.The engineer went to the er, and the x-rays showed no broken bones or fractures.The engineer only complained of sore shoulder and limited movements.

Manufacturer Narrative

The investigation was performed on expert discussions (considering complaint description, cs reports, system history, system log files).The service documentation provides adequate guidance on how to perform repairs safely.In addition, only trained personnel are used for service activities.This case is classified as an accident at work due to improper workmanship.No system failure was identified that could have caused this accident.The occurrence rate of the aforementioned error pattern was checked.No similar cases have been communicated within 14 years of service.

• Brand Name: SIREMOBIL COMPACT L
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234197
• MDR Report Key: 17425359
• MDR Text Key: 320672238
• Report Number: 3004977335-2023-00069
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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: 03780629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/17/2023
• 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 Age: 41 YR
• Patient Sex: Male