MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS PHENO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10849000

Device Problem Mechanical Problem (1384)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.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

It was reported to siemens that a malfunction occurred while operating the artis pheno system.The user reported that after leaning sideways against the table top with the column brake locked, the table column or table top rotates.It does not return to its original position after the load is removed and the table rotation is inaccurate.There is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

The investigation revealed that the problem mentioned in the complaint was not caused by the siemens x-ray system, but by the autonomous medical product of the manufacturer getinge.According to the investigation and the available information, the situation on site was as follows: after a person leaned sideways against the tabletop of the product "maquet magnus table (getinge)" with the column brake locked, the table column or tabletop of the patient table twisted.It did not return to its original position after the load was removed.The problem was investigated by the table manufacturer, getinge.A technician went on site and found that the table's height guide screws were loose.This caused mechanical play, resulting in lateral inaccuracy.The lateral overlay error in this case is on the scale of +/- 4 mm.The problem described was solved by the getinge technician fixing the screws.This was the first time such a problem of the maquet patient table had been brought to our attention.Therefore, this case is considered a singular event.Neither a general, nor a systematic problem was identified.A possible general fault that would require corrective action of the installed base could not be identified by the investigation.After a thorough investigation, the incident described in the adverse event is not classified as a reportable event because no malfunction of the system could be detected and the described error related to a third-party product, which is a medical device on its own.

• Brand Name: ARTIS PHENO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11811613
• MDR Text Key: 250822394
• Report Number: 3004977335-2021-79705
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (y/n): N
• PMA/PMN Number: K163286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10849000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1