• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500 SYSTEM Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7383370
MDR Text Key104030859
Report Number2517506-2018-00228
Device Sequence Number1
Product Code JJE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051087
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberDIMENSION VISTA 1500 SYSTEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/04/2018
Initial Date FDA Received03/29/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/22/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-