MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported smoke and a burning smell coming from the rear left-side exhaust fan of a dimension vista 500 instrument.The customer stated that they stopped the instrument; the visible smoke ceased, but the burning smell persisted.The customer confirmed that there was no fire or visible sparks observed, no injuries occurred, and no medical intervention was required.There are no known reports of adverse health consequences due to the event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported smoke and a burning smell coming from the rear left-side exhaust fan of a dimension vista 500 instrument.The customer stopped the instrument.The customer inspected the instrument but was unable to identify the exact source of the smoke.Siemens remotely assisted the customer and advised the customer to turn off the customer bulletin 1(cb1) switch as a precautionary measure.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse removed all the panels in the rear of the machine and found a smoke smell coming from the fan and the climate control module (ccm), replaced both, calibrated the ccm and removed all the flexes and vial carriers.Then, the cse performed quick check, which recovered acceptably.Siemens further evaluated the event and concluded that the malfunctioned heat exchanger fan and the climate control module (ccm) due to normal wear potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• 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 number: 1226181; brookfield CT 06804
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22492416
• Report Number: 2517506-2025-00108
• Device Sequence Number: 8112765
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 07/14/2025

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 VISTA 500
• Device Catalogue Number: 10284473
• 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: 06/29/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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