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

Model Number	DIMENSION VISTA 500 INSTRUMENT
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the external uninterruptible power supply (ups) failed, causing a loud popping noise, an electrical smell, and visible smoke on the dimension vista 500 instrument.The customer stated that there were no visible sparks or fire associated with the smoke.There was no injury to the patient, user, or operator due to the event.There are no known reports of adverse health consequences due to the reported event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an external uninterruptible power supply (ups) failed, causing a loud popping noise, an electrical smell, and visible smoke, on the dimension vista 500 instrument.This led to the instrument and ups shutdown.The siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and identified that the ups malfunctioned.The cse replaced, configured and powered up the ups, and ran a quick check, which passed.Siemens further evaluated the event and concluded that the malfunctioned ups potentially contributed to the reported event.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA 500 INSTRUMENT
• Common Device Name: DIMENSION VISTA 500 INSTRUMENT
• 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: 22209358
• Report Number: 2517506-2025-00100
• Device Sequence Number: 8149287
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 06/16/2025

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 INSTRUMENT
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/16/2025
• 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