MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARISTOS VX PLUS; STATIONARY X-RAY SYSTEM

Model Number 05895003

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).First analysis was performed based on information received from (b)(4).It was determined that other xp products may be experience the same issue.The preliminary analysis showed that the steel ropes inside the lifting column of the overhead tube may rupture.The probability of such occurrence depends on the degree of system usage and is accessed as extremely rare.According to current design, there are two steel ropes inside the lifting column - primary steel rope and safety steel rope.The primary steel rope is used in regular operation to carry the load of the ceiling stand.The safety steel is used as a backup to carry the load in case the primary steel rope fails.The safety steel rope may only be loaded in single fault conditions and is not designed to take over load stepwise or permanently during operation.In order to avoid such occurrences in the field siemens healthcare (b)(4), diagnostic imaging, x-ray-products is preparing to issue two field safety corrective actions.A field safety notice (update instruction xp012/18/s) will inform the affected customers about the potential issue and further corrective activities of the manufacturer.Primary steel rope used in the lifting column will be inspected in all affected systems and exchanged if negative deterioration is identified.An additional safety mechanism will also be installed to block further operation unless the problem is corrected.This corrective action will be released via an update instruction xp011/18/s.

Event Description

The manufacturer siemens healthcare (b)(4), diagnostic imaging, x-ray-products (xp) was informed by its partner organization, (b)(4), that during an incident investigation, awareness was gained that other products of the same product line (xp organization) may be affected.The investigated event that raised awareness occurred in (b)(6) on the axiom aristos vx unit.The tube arm of the axiom aristos vx plus dropped down during patient positioning, however, neither the patient nor operating personnel were injured.The reported event occurred in (b)(6).

• Brand Name: AXIOM ARISTOS VX PLUS
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty boulevard; malvern, PA 19355 ; 6104486478
• MDR Report Key: 7497932
• MDR Text Key: 107710198
• Report Number: 3002808157-2018-23410
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061054
• 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
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 05895003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2018
• Date Manufacturer Received: 04/09/2018
• 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