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

Model Number 10848283

Device Problem Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The assessment of the log information does not indicate a system failure or malfunction and no non-conformity was identified.The root cause was determined to be a user error.The operating manual contains adequate instructions and information for safety regarding patient positioning and securing the patient.The process of patient transfer and positioning is under the control of the operator.That includes the table top, the mattress, fixation accessories, the alignment of the material and the patient on the table and proper execution or fixation performed by the operator including spending appropriate attention to the patient depending e.G.Their consciousness.(b)(6).

Event Description

It was reported to siemens that an adverse event occurred prior to examination on the artis zeego.Q system.A patient suffered an injury to the shin when climbing onto the system table.The patients shin struck the end of the accessory rail resulting in a puncture wound.The patient required surgery to treat the wound.

• Brand Name: ARTIS ZEEGO.Q
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 8482583
• MDR Text Key: 140901919
• Report Number: 3004977335-2018-37154
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10848283
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2018
• 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): Hospitalization