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

Model Number	10094137
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted when either new information is received or at the conclusion of the investigation.
Event or Problem Description
Siemens became aware of an incident that occurred while operating the artis zee ceiling system.The patient was left unintended in the exam room.It was reported that the patient fell off the table approximately 1.2 meters ( = 3.937 feet) down.The patient passed away due to the skull injuries.Additional information was provided that there was no equipment failure.A causal relation between the patient death and the medical device could not be established.
Additional Manufacturer Narrative
The investigation of the reported incident was completed.The investigation revealed that the patient was not immobilized by the velcro straps provided to the user.No table movement or tipping occurred either.Additional information was received that the patient tried to get off the table without medical personnel assistance and fell down.The patient hit his head on the floor.It was confirmed that following the incident the patient remained conscious and responsive.However, the patient reported a headache and some wrist pain.On (b)(6) 2023, on the following day a head scan was performed as the headache persisted.Intracranial bleeding was found.The patient remained conscious at this time.On (b)(6) 2023, the patient passed away in his hospital room.The investigation showed that no system failure or malfunction occurred at the time of event.It is operator¿s responsibility to ensure that patient is immobilized.This process includes the tabletop, the mattress, the fixation accessories, the alignment of the material and the patient on the table.The operator must proper execute the fixation as well as pay attention to the patient.The instructions for use provide adequate guidance on how to secure patients during examination.The occurrence rate of the error pattern was checked.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.
Additional Manufacturer Narrative
7/18/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• Brand Name: ARTIS ZEE CEILING
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18347843
• Report Number: 3004977335-2023-00164
• Device Sequence Number: 6269049
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: (01)04056869010052(21)148214
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10094137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 02/21/2024; 07/18/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/22/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown