MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI SYSTEM

Model Number	IMMULITE 2000 XPI SYSTEM
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.The cse found the immulite's transformer had two terminals melted.The cse checked the laboratory's electrical outlet that powered the immulite and found its output to be within specifications.The cse then replaced the immulite's transformer.The system was then inspected for all voltages and passed all system checks.The issue was resolved by routine troubleshooting.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer contacted siemens and reported that the transformer of the customer¿s immulite 2000 xpi system had caught fire and melted wires.It is unknown if there were visible smoke or flames as the customer was not in laboratory when the event happened.No burning smell was noted but the system was down due to the issue.There was no delay in testing as the customer had backup systems to process samples.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: IMMULITE 2000 XPI SYSTEM
• Common Device Name: IMMULITE 2000 XPI SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 2247117; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 19485081
• Report Number: 2247117-2024-00008
• Device Sequence Number: 7906044
• Product Code: JJE
• UDI-Device Identifier: 00630414945422
• UDI-Public: 00630414945422
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K970227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: IMMULITE 2000 XPI SYSTEM
• Device Catalogue Number: 10373214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/07/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown