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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+ Back to Search Results
Catalog Number 10379678
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
Siemens service stated that the fuse was replaced and the plug was exchanged and the instrument is operational.There was no harm done to any patient, operator or siemens personnel.
 
Event Description
The customer reported that when field service was installing the clinitek status+, there was a short circuit in the two parts of the power supply and the fuse blew.A puff of smoke was seen.There were no patient samples being run.There was no report of injury do to this event.
 
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Brand Name
CLINITEK STATUS+
Type of Device
CLINITEK STATUS+
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern road
chilton industrial estate
sudbury, CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
tim krauskopf
2 edgewater drive
norwood, MA 02062
8622285388
MDR Report Key8209953
MDR Text Key132224225
Report Number3002637618-2019-00001
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K091216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/02/2019
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 Health Professional
Device Catalogue Number10379678
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2018
Initial Date FDA Received01/02/2019
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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