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

Model Number 10762471

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/11/2021

Event Type  Injury  

Event 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.

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).

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 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.

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
• Type of Device: 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
• MDR Text Key: 285994518
• Report Number: 3004977335-2021-04850
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869009155
• UDI-Public: 04056869009155
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10762471
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other