MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS DRF MAX; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10762471
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens became aware of an incident that occurred on the (b)(6) unit.The overhead tube dropped and hit the operator present in the room.The technical was evaluated for a head injury, however, no medical treatment was required and the technical returned to work the next day.The unit was returned to everyday operation and no issues have been reported.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
Siemens became aware of an incident that occurred on the luminos drf max unit.The overhead tube dropped and hit the operator present in the room.The technical was evaluated for a head injury, however, no medical treatment was required and the technical returned to work the next day.The unit was returned to everyday operation and no issues have been reported.
Additional Manufacturer Narrative
The issue was investigated in detail.The affected system at customer site was inspected by a service technician and did not show any malfunctions.According to the information received, the system was found in normal condition and a proper system operation was verified.The provided data, log files and flight recorder log files of the day of incident were investigated in detail.No abnormal or unintended movements and no error messages could be identified.Based on the given information and the analysis of this issue, no malfunction of the system could be determined.A possible explanation could be that the system was moved by an operator without checking if the movement path was free of persons (operator manual xpd3-520.620.01.01.02, chapter "general safety", page 31/80).

• Brand Name: LUMINOS DRF MAX
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12843599
• Report Number: 3004977335-2021-04850
• Device Sequence Number: 11914444
• Product Code: JAK
• UDI-Device Identifier: 04056869009155
• UDI-Public: 04056869009155
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 10762471
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/25/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown