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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+ Back to Search Results
Catalog Number 10379675
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2014
Event Type  malfunction  
Event Description
The customer reported discordant results between instrument and other unit.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer had been requested to perform precision study but they did not provide specific results of precision survey.Customer indicated that the unit is operational and they have not had any further issues.Customer indicated that they will not be pursuing this issue any further.The cause for the discordant results is unknown.
 
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Brand Name
CLINITEK STATUS+
Type of Device
CT STATUS+
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 Key4223298
MDR Text Key17997399
Report Number1217157-2014-00165
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2014
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 Other
Device Catalogue Number10379675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/06/2014
Initial Date FDA Received11/04/2014
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
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