MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report smoke emitted from the uninterruptible power supply (ups) load input cable connection, which was connected to the dimension exl with lm instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse found a burnt ups load output plug.The cse replaced the cord using a bypass cable.The customer performed a system check and ran quality controls (qc) which were found to be acceptable.Siemens determined that normal wear potentially contributed to the burnt ups load output plug.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that smoke and an electrical and/or plastic burning odor emitted from the uninterruptible power supply (ups) load input cable connection, which was connected to the dimension exl with lm instrument.The instrument switched off and there was no power to the main printed circuit board.The customer removed the ups power cords from both the output and input and turned the ups off.Siemens requested for the customer to unplug the instrument from the wall outlet; however, the customer was unable to identify the cord for the dimension exl with lm.The customer powered off the reagent management system (rms).There was no impact to patient testing as the customer was able to process patient samples on an alternate instrument.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: DIMENSION EXL WITH LM
• Common Device Name: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 17314925
• Report Number: 2517506-2023-00159
• Device Sequence Number: 11771423
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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: DIMENSION EXL WITH LM
• Device Catalogue Number: 10472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2012
• 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