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

Model Number 10848282

Device Problem Sharp Edges (4013)

Patient Problem Injury (2348)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.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 the artis q biplane system, the patient rolled over the table and their hand went under the table resulting in mild laceration or abrasion.The patient's hand wound was treated with liquid bandage.Additional information has not been made available to siemenes.Siemens has requested additional information in order to investigate the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The investigation showed that the problem was not due to a malfunction of the system, but to misbehavior.The photos provided clearly showed that the affected areas of the system had already been damaged.Damage was clearly visible, most likely resulting from previous collisions with undefined objects.This damage can lead to sharper corners and edges than a system without damage.The damaged areas were inspected in the laboratory on a similar system and examined for possible danger spots in general.In particular, iec 60601-1:2012, "clause 9.3 mechanical hazard associated with surfaces, corners and edges" was taken into account.With the undamaged system, neither too rough spots nor too sharp corners or edges were found.Therefore, there is no systematic defect and the system complies with the specifications.Additionally, the instructions for use (ifu) point out possible dangerous spots and the one given is also explicitly marked on the device with a pinch point sticker.It is the operator's responsibility to ensure the appropriate safety when positioning or repositioning the patient.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10367494
• MDR Text Key: 201865876
• Report Number: 3004977335-2020-37413
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1