MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS DRF; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094200

Device Problem Mechanical Problem (1384)

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

Event Date 07/03/2021

Event Type  malfunction  

Manufacturer Narrative

The user has not yet noticed the tube column was slightly loose.Normally the operator would notice that the beam is not centered correctly if the tube column is loose.According to the operator manual, a daily check of the system must be performed before use.Therefore, it is highly unlikely that the screws would become completely detached.The issue would be detected by the user and addressed by service personnel.However, if the daily check is not performed correctly and the user ignores other signs, in the worst case the tube could detach and fall, causing serious injuries to persons.Investigation is ongoing.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

According to the information provided to siemens, a service engineer was dispatched to a customer site to replace the tube unit on the axiom luminos drf system installed in 2011.While replacing the part, the engineer found that the tube column was loose.The provided video shows that the engineer was able to shake the column slightly with his hand.The engineer also noticed that the mounting screws connecting the column and the base were loose.Some of the screws were missing loctite, as required per the installation instructions.There are no injuries attributed to this event.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.During a service visit the service technician found that the tube column was not properly attached as it could be shaken by hand.He also found that some screws were loose, and no loctite was applied.The investigation of the provided pictures and the video showed the affected loose screws and a gap between table support unit and column.The root cause was determined as an issue in workmanship that occurred during the installation of the system at the customer site.According to the information received the system was repaired in the meantime by local service technician with applying loctite 221 to the mounting screws.For transportation to the customer, the column unit was detached from the table support unit.The local installation team had to connect it again properly according to the installation instruction.In the installation instruction "axd3-500.812.01.21.02|04.13", chapter 5.1 "installing the column" it is described that for the affected screws "loctite 221" must be used.And according to the provided information from the service technician, loctite was missing on those screws.Furthermore, additional concerns were communicated by the service technician that a torque inspection was missing in the maintenance protocol for these screws.There is no way of checking the torque for screws that are secured with loctite as applying further torque to screws with dried loctite at the thread would cause loctite to crack and make it useless.In such cases, the screws would have to be replaced with new screws and fresh loctite.For this reason, there is a special paragraph in the installation protocol, which shows the importance of correctly applied torque, as described in the installation instruction (safety relevant installation work steps).This also must be signed separately within the protocol.In general, according to the operator manual xpd3-500.620.01.01.02, a daily check of the system must be performed by operator before use.If there are any deviations detected during visual inspection, the service organization must be contacted.

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12349294
• MDR Text Key: 267678774
• Report Number: 3004977335-2021-93924
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094200
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other