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

Model Number 475517

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

The system was brought back to specifications.The reported issue is under investigation and a supplemental report will be submitted if additional information becomes available.This report was submitted february 24, 2016.Customer's address: (b)(6).

Event Description

During a routine system maintenance, siemens service team discovered that all m8 screws on the transverse carriage were missing and 3 out of 4 bolts were loose.The unit was immediately brought back to specifications and "safe to use" state.There are no injuries associated with this event.The report event occurred in (b)(6).

Manufacturer Narrative

The investigation of the provided issue showed that the screws were retained with loctite however not completely tightened with torque.Due to the low pre-load of the bolted joints a relative movement (play) between rail and supporting plate exists.This relative movement resulted in another move-behavior of the connection component and led to loosening of the bolted joints.Due to the not strongly tightened bolted joints of the transverse carriage a displacement of the trolley is possible.This is only possible if all screws of the supporting plates are not properly bolted and all locking pins are released off the rail.Therefore the displaced trolley at the transverse carriage could slide off the rail.There was no displacement of the trolley at the concerned customer site.The factory installation team discovered the loose screws during a site visit for a planned service interaction and the issue was addressed internally.A single workmanship error in production was identified as a root cause for the loosened screws.A systematic failure in production can be excluded as systems in the field were checked and no failure could be determined.Furthermore the maintenance records were checked as well and no abnormalities could be identified.For prevention of this issue an additional step was appended in the maintenance instruction.Siemens will continue to systematically check maintenance records.

• Brand Name: AXIOM MULTIX TOP
• Type of Device: TABLE, RADIOGRAPHIC, NON-TILTING, POWERED
• Manufacturer (Section D): SIEMENS GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern 19355 ; 6104486478
• MDR Report Key: 5457095
• MDR Text Key: 39424510
• Report Number: 2240869-2016-00698
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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