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

Model Number 10094139

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 09/12/2019

Event Type  Injury  

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 an adverse event occurred while operating the artis zee multi-purpose system.During a procedure, the user reported that the fd fell down and touched the patient's chest.As a result, the patient received a chest x-ray.At this time, 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

Siemens has completed an investigation of the reported event.The root cause was determined to be a workmanship error.The original complaint alleged "falling down of the fd", i.E.A dropping of the flat detector (fd), however, the on-site investigation revealed that the fd which is suspended on both sides tilted down on one side while the other side remained connected to the system.This was the result of an unsuitable screw length of m8x40mm on the tilted side which is contrary to the specification of m8x50mm.During analysis of the manufacturing history and processes it was determined that the system was originally supplied with the appropriate screws but was subsequently modified.This is supported with information that the system was moved from its original location to another room at the customer site.In all probability, the incorrect screws were used when re-installing the system.In particular, the screws used are too short and correspond to those used on the transport frame of the system during the move.Additionally, these screws are not used in the supplier's production.The use of the incorrect screws violates the assembly instructions.The system was examined and repaired on-site by a siemens product specialist and the error did not reoccur.An individual work error on the part of the installer was the cause for the error and evaluation of the history does not show any accumulation of errors.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARTIS ZEE MULTI-PURPOSE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, 91301 ; GM 91301
• MDR Report Key: 9070268
• MDR Text Key: 159938076
• Report Number: 3004977335-2019-98168
• 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,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094139
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other