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

Model Number 08630506

Device Problems Radiation Leak (1357); Radiation Output Failure (4027)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

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.

Event Description

Siemens became aware of an incident that occurred while operating the siremobil compact l (3) system.The footswitch was stuck causing the system to release radiation unintentionally for 5 minutes.Siemens has requested additional information to continue with the investigation.We have no indications of any adverse effects on the health status of the persons involved.

Manufacturer Narrative

H3, h6: the detailed investigation of the complaint event and system was completed.The investigation was performed based on expert discussions considering complaint description, customer service reports, and system history.According to the initially provided information, x-ray radiation was unintentionally triggered by the system without the footswitch being actively pressed.This problem occurred during system testing, performed by a physicist.The user recognized the unwanted radiation by the radiation alarm that sounds after 5 minutes of continuous exposure.The worst-case estimate (including the assumption, that the physicist remains directly in the x-ray path for the whole time period) of the potentially applied skin dose gives a maximum value of 225mgy.No health consequences were reported to this event.The onsite service intervention showed that the spring of the footswitch was missing, which causes the foot pedal to require less force to be actuated.Unfortunately, it was not possible to determine how the spring was lost.In addition to the alarm signal that informs the user after 5 minutes, ongoing radiation is displayed via an ¿x-ray¿ lamp.No issue was identified when checking the optical signal.To resolve the problem, the footswitch was replaced as part of the service activity.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.

• 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 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17682212
• MDR Text Key: 322620255
• Report Number: 3004977335-2023-00105
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 04056869008998
• UDI-Public: 04056869008998
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K963093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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: 08630506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 11/29/2023
• 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