MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500 SYSTEM

Model Number DIMENSION VISTA 1500 SYSTEM

Device Problem Device Issue (2379)

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

Event Date 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the site.The cse inspected the dimension vista 1500 system.The cse ran server 3 (s3) service methods and found that the s3 mix test failed.The cse replaced then auto-aligned the s3 mixer.The cse repeated the s3 service methods with passing results.The cse ran three levels of control material for carbon dioxide with no outlier results.The cause of the discordant falsely low carbon dioxide (co2) test results is a faulty s3 mixer.The device is performing within manufacturing specifications.No further evaluation of the device is required.

Event Description

Discordant falsely low carbon dioxide (co2) patient sample test results were obtained on a dimension vista 1500 system.The initial results were reported to the physician(s).The same samples were repeated on an alternate dimension vista 1500 system.The repeat results from the alternate dimension vista 1500 system were reported to the physician(s) as corrected results.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely low carbon dioxide (co2).

• Brand Name: DIMENSION VISTA 1500 SYSTEM
• Type of Device: DIMENSION VISTA 1500 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.; registration #: 1226181; 101 silvermine road; brookfield DE 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 7383370
• MDR Text Key: 104030859
• Report Number: 2517506-2018-00228
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DIMENSION VISTA 1500 SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1