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

Model Number 10762471

Device Problem Installation-Related Problem (2965)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

The customer installed two systems in a very small room.The installed systems include a siemens healthineers luminos drf max and a system for orthopantograms by a different manufacturer.A siemens healthineers service engineer observed that there is hardly any space to walk through the room.Siemens has requested additional information from the customer regarding the installation and the foreign manufacturer¿s system.Siemens healthineers has not been made aware of any adverse events associated with this room situation.However, in worst case scenario due to the room configuration, crushing of a patient or operators by a system may occur and result in a serious injury.

Manufacturer Narrative

A customer facility contact name was not provided to siemens.The complaint was initiated by siemens.The customer facility phone number is (b)(6).The investigation is ongoing.A supplemental report will be submitted if addition information becomes available upon completion of the investigation.

Manufacturer Narrative

G4: 510(k) number was omitted in error in the initial report submitted to the fda on 03/08/2023 and provided in this supplemental report.

Manufacturer Narrative

H10 manufacturer narrative: siemens healthcare investigated the reported issue in detail.It was stated that in the same room as the luminos drf max system there is an orthopantogram op100 by a different manufacturer.As a result, there is hardly any space to walk through the room.According to the information received, the orthopantogram op100 was installed in the room after the luminos drf max system.Based on the information received from the service organization, it can be concluded that there is no technical problem with the luminos drf max system.The provided images show that the orthopantogram op100 is located at the head end of the luminos drf max.According to the received room plan, the luminos drf max could be operated within the normal parameters without the additional system.The provided images show that there is only 7cm space between the extracted tabletop and the other system.It is described in the startup instructions that a general safety distance of 50cm from the tabletop must be maintained (see xpd3-520.815.03.10.02|11.22 chapter 4.3 ¿ room dimensions).When the tabletop is fully extended toward the head, the required safety distance is not maintained in certain positions of the system.Therefore, the movement range of the tabletop in the head area must be limited.It is also described in the startup instructions how to program the current room dimensions, limitations, and additional obstacles (see xpd3-520.815.03.10.02|11.22 chapter 4.3.1 ¿ entering the room dimensions, chapter 4.6 ¿ handling obstacles).The customer was advised not to use the system in the current situation.If the customer refuses to accept a restriction on system movements, written confirmation is required that the customer is aware of the risk and accepts responsibility.The complaint was closed with this statement.

• Brand Name: LUMINOS DRF MAX
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 65-1a; 65-1a; malvern, PA 19355 ; 8483234198
• MDR Report Key: 16503632
• MDR Text Key: 311109622
• Report Number: 3004977335-2023-00013
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K173639
• 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,Followup
• Report Date: 04/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762471
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1