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

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported observing a spark while attempting to troubleshoot a dimension vista 500 instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse found that the monitor was defective, and the power cord was stripped.The cse replaced the monitor and power cord and ran a system check with results within acceptable parameters.Siemens further evaluated the event and concluded that the power cord issue and the monitor's defect potentially contributed to this event.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reportedly observed a spark while attempting to troubleshoot a dimension vista 500 instrument.The instrument monitor was unresponsive due to a damaged power cable and the customer tried to troubleshoot the damaged cable and observed a spark.There are no known reports of visible flames, smoke, injury, nor adverse health consequences due to the event.

• 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# 1226181; brookfield CT 06804
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21983780
• Report Number: 2517506-2025-00074
• Device Sequence Number: 12840410
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/08/2025

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: 04/17/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2011
• 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