MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM.

Model Number	DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM.
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report that smoke was emitted from a dimension exl 200 integrated chemistry system.The customer powered off the instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse observed a ¿waste bottle full¿ error and a burning smell, which led the cse to check the waste and vacuum pumps.The cse determined that a malfunctioning waste pump was not discharging waste and caused an overload, which blew the fuse responsible for the vacuum pump.The cse replaced the vacuum pump, the vacuum fuse, and the waste fuse.Additionally, the cse verified the electro-mechanical operations of the waste bottle, float, and associated circuitry during the instrument diagnostics, all of which were acceptable.Next, the cse performed a successful system check.Based on the available information, siemens concluded that an occluded waste bottle assembly, which caused the waste pump to overheat during the waste pump¿s attempt to remove waste from the bottle, potentially caused the event.This analyzer is a ul listed analyzer and conforms to the requirements that materials used will not lead to an open flame.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that smoke was emitted from the dimension exl 200 integrated chemistry system.The customer powered off the instrument and stored the pending samples in a refrigerator and processed the samples on the following day.There are no known reports of injury or adverse health consequences due to the event.

• Brand Name: DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM.
• Common Device Name: DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM.
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ
• Manufacturer Contact: douglas stanton ; 511 benedict ave.; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 20895961
• Report Number: 2517506-2024-00302
• Device Sequence Number: 21066373
• Product Code: JJE
• UDI-Device Identifier: 00842768037214
• UDI-Public: (01)00842768037214
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 12/10/2024

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: DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM.
• Device Catalogue Number: 10636928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2019
• 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