MAUDE Adverse Event Report: MULTIX TOP; TABLE, RADIOGRAPHIC, NON-TILTING, POWERED

Model Number 475517

Device Problem Mechanical Problem (1384)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.A root cause has not yet been determined.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

An issue occurred with a multix top system.The user reported that the bolt from the 3d carriage conduit mount dropped and one of the cables became free.There is no report of impact to the state of health of any patient or user involved.At this time, the system has been taken out of use.Siemens has requested additional information in order to conduct an investigation of the reported event.The issue is reported in doubt.

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided pictures showed that the grooved hose holder from the transverse carriage had detached and fallen.The description in the complaint text "bolt hit the floor" could not be confirmed, only the small screw nut hit the floor.The grooved tube stopped at a height of approx.60 cm over the tabletop.It was determined that the cause of the grooved hose with the cable holder falling was the loosening of the nut from the bolt on the cable holder.It is assumed that the screw connection of the holder was secured without any loctite, which allowed the connection to get loose over time.It could not be determined whether the connection was not secured with loctite during production or through service measures.However, the sleeve does not make any downward rotation during fall; only at the end of falling the sleeve is rotated.This was simulated and confirmed in the test laboratory.The sleeve of the cable holder is made of plastic.According to the information received from local service, the holder on site was reattached, inspected and the mounting was tested.The connection was secured with loctite.No further measures are necessary at the concerned customer site.It was stated that there was no evidence of loctite on the threaded part of the hanger.Based on the instructions, the screw connection must be secured with loctite during installation.The manufacturing documents were screened and were found as correct.However, it was decided to specify the maintenance instructions in more details as a preventive measure.General inspection of the grooved hose holder must be substituted by a detailed inspection of the cable holder during maintenance.This inspection will be described more explicitly in the maintenance protocol.

• Brand Name: MULTIX TOP
• Type of Device: TABLE, RADIOGRAPHIC, NON-TILTING, POWERED
• MDR Report Key: 12048606
• MDR Text Key: 257702959
• Report Number: 3004977335-2021-85157
• Device Sequence Number: 1
• Product Code: IZZ
• Combination Product (y/n): N
• PMA/PMN Number: K971452
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 475517
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other