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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 10332185
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 04/10/2019
Event Type  malfunction  
Manufacturer Narrative
The customer has been advised to stop using the power cord and a replacement power cord has been supplied which resolved the issue.The customer is operational.
 
Event Description
The customer reported that the power cord to the clinitek status has begun to fray, exposing wires, and was no longer powering the instrument consistently.There was no report of injury due 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 Key8551422
MDR Text Key145264887
Report Number3002637618-2019-00051
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031947
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 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10332185
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/10/2019
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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