MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION VISTA 1500

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The ccc specialist was made aware that the aliquotter belt was broken and replaced, and that laboratory personnel did not have to evacuate as a result of the spark and smoke that was emitted by the instrument.A siemens customer service engineer (cse) was dispatched to the customer site.The cse inspected the instrument and resolved the issue by replacing the control servo hybrid printed circuit board, chain cable timing 4p x 2500l poly, c-drive vertical assy aliquotter, ionizing fan service kit, aligning the auto and manual aliquot probe and the reagent shuttle 2.The issue is resolved, and the instrument is operational.No further evaluation of this device is required.

Event Description

The operator observed a spark and smoke emitting from the dimension vista 1500 instrument.The were no visible flames or reports of damage to property.There are no known reports of adverse health consequences due to the smoke being emitted.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• 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: rolando hualpa ; 511 benedict ave; tarrytown, NY 10591 ; 9145242963
• MDR Report Key: 7664851
• MDR Text Key: 113299593
• Report Number: 2517506-2018-00406
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1