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

Model Number 10280959

Device Problem Leak/Splash (1354)

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

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(6).

Event Description

It was reported to siemens that an adverse event occurred while operating the artis zeego system.The facility reported that water leaked from the x-ray tube and spread across the floor.A male technician slipped and fell resulting in a cut to the hand.It is not known if medical treatment was needed.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause could not be determined as the affected component was not returned for evaluation.The customer service engineer (cse) was contacted due to a fluid leak on the system.When the cse arrived, he slipped on a puddle of water, fell down and slightly injured his hand.Later, the involved cse found the x-ray tube cooling unit defective.An extensive investigation could not be performed as the cooling unit was not returned for a detail investigation.Therefore, the exact circumstances at the time of the event could not be reproduced retrospectively.The x-ray tube cooling unit has been exchanged by the local service organization and the error mentioned did not reoccur.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARTIS ZEEGO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8319822
• MDR Text Key: 135503679
• Report Number: 3004977335-2019-67119
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10280959
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other