Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 DCA VANTAGE
  • 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 DCA VANTAGE Back to Search Results
Catalog Number 10282969
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2014
Event Type  malfunction  
Event Description
Customer reported discordant hemoglobin ((b)(6)) results on the instrument.There was no report of injury due to this event.
 
Manufacturer Narrative
The cause for the discordant hemoglobin (b)(6) results is unknown.
 
Manufacturer Narrative
Customer stated that all is working well after training and does not require any follow up contact.Customer received an exchange instrument for customer satisfaction, and is operational after having been re-trained.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DCA VANTAGE
Type of Device
DCA
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern road
chilton industrial estate
sudbury CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key4210424
MDR Text Key4985444
Report Number1217157-2014-00164
Device Sequence Number1
Product Code LCP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number10282969
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/30/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-