MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG LUMINOS LOTUS MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	11574100
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers was notified of an issue related to customer safety advisory notice xp017/24/s with the luminos lotus max system.At the attachment of monitor ceiling suspension, the securing segment was not installed correctly.The monitor support arm remained attached to the ceiling and no injury occurred.It is assumed that in a worst-case scenario, if the support arm had been used further without noticing the issue, it might have led to a serious injury by large parts falling down and hitting a person.
Additional Manufacturer Narrative
Initial corrective actions/preventive actions implemented by the manufacturer: the system was taken out of use as instructed by customer service advisory notification (csan) xp017/24/s which began distribution to affected customers on 07/02/2024.Siemens initiated recall res# 94948, which was submitted to the fda on 07/05/2024 for potential problems with the support arm of select system ceiling displays or wall displays.Manufacturers preliminary analysis: the root cause for the issue has not yet been determined.The investigation is ongoing.The root cause will be communicated via res# 94948.Corrective and or preventative actions will be implemented via resolution updates xp018/24/s and xp019/24/s.These updates are anticipated to be released in september 2024.A supplemental report for this complaint event will not be submitted to the fda.
Additional Manufacturer Narrative
H11 corrected data: a supplemental report will not be submitted to the fda since the issue will be investigated and resolved via resolution updates xp018/24/s and if necessary xp019/24/s.

• Brand Name: LUMINOS LOTUS MAX
• 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 19804313
• Report Number: 3004977335-2024-00081
• Device Sequence Number: 12700066
• Product Code: OWB
• UDI-Device Identifier: 04056869269931
• UDI-Public: (01)04056869269931
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11574100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 07/23/2024
• 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
• Patient Sex: Unknown