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

Model Number 10094137

Device Problem Unintended Electrical Shock (4018)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

H10: additional manufacturer narrative: e1: a customer facility contact name and telephone number were not provided for reporting purposes.H3, h6: siemens has initiated a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplemental report will be filed if additional information becomes available upon completion of the investigation.

Event Description

It was reported to siemens healthineers that a person received an electric shock during the installation of a power cable.There was no indication of any adverse health effects associated with this event.

Manufacturer Narrative

During the installation of a monitor power cable inside the display ceiling suspension (dcs), the service engineer touched open contacts and received an electrical shock.An ecg and a blood sample were taken.No health consequence has been identified.It was found that the plugs of the cables connected to the brake buttons in the dcs were bent upwards and pulled out a few millimeters from the socket.This created a non-isolated contact measuring several millimeters.According to our experts, the most likely root cause of the reported issue was improper workmanship during installation of additional cables inside the dcs.The plug is designed to be plugged in or pulled out by force, and no tension could be caused on the plug by moving the dcs to different positions.Furthermore, the dcs must be disconnected from the power source before opening.The service manual (cb-doc) provides instructions on how to observe the basic safety rules for installation, maintenance, and service.Caution should be exercised when performing measurements and tests for troubleshooting.No work may be carried out on components with a voltage of more than 25 v ac/60 v dc.Siemens is unaware of any similar events in the field.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: ARTIS ZEE CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843274197
• MDR Report Key: 17388218
• MDR Text Key: 319666386
• Report Number: 3004977335-2023-00066
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: 04056869010052
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10094137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female