MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT ARTIS ZEE BIPLANE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094141

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hair Loss (1877)

Event Date 01/19/2023

Event Type  Injury  

Event Description

An adverse reaction was reported by a patient to siemens.Following an embolization procedure on the artis zee biplane, the patient complained of hair loss.Siemens has requested additional information in order to conduct an investigation of the reported event.

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 if additional information becomes available.

Manufacturer Narrative

H10: manufacturer narrative: h3, h6: siemens healthineers completed the investigation of the reported event.The investigation was performed based on expert discussions, consideration of the complaint description, customer service reports, system history, and log file analysis.On january 19, 2023, siemens healthineers was informed that a patient complained of hair loss after embolization procedure.The patient had experienced six (6) embolization treatments between march 2022 and december 2022.The last two (2) treatments were on december 20, 2022 and december 24, 2022.The patient reported hair loss afterwards.From the last two (2) treatments, patient received approximately 3.5 gy from plane-a and around 1 gy from plane-b.The 3.5 gy dose from plane-a was mostly completed with projections from the same angle.This could possibly result in hair loss.The detailed technical investigation revealed that the recorded dose values are in accordance with the system settings and imaging conditions and comply with the applicable regulatory requirements.No system malfunction was identified for the claimed effect.The system did not contribute to the communicated effect outside of the operator's control.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error which leads to corrective action, could not be determined by the investigation.No malfunction of the system could be detected.This complaint has been closed.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4943234198
• MDR Report Key: 16263644
• MDR Text Key: 308360122
• Report Number: 3004977335-2023-60759
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other