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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CLINITEK STATUS +
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SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CLINITEK STATUS + Back to Search Results
Catalog Number 10379675
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 10/07/2019
Event Type  malfunction  
Manufacturer Narrative
Siemens has requested the connect base to be returned for investigation.The cause of this event is unknown.
 
Event Description
The customer reported seeing smoke coming from the connect base to the clinitek status+.They have disconnected the base and are using the clinitek status+ independently.There was no report of injury due to this event.
 
Manufacturer Narrative
Tech ops has completed the investigation: the clinitek status base was received from the customer in good condition.The status instrument attached to the base, was not included.No power supply was present.The transformer t2 on the status xl basecomm board was cracked and slightly melted.The transformer t2 is the source of the burning smell but is not a fire risk.The transformer is connected to the 9v power supply.The power supply connection point is a standard connection, therefore an incorrect power supply could have been connected causing the current to be higher than the transformer can handle.
 
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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
MDR Report Key9226736
MDR Text Key164915796
Report Number3002637618-2019-00114
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
PMA/PMN Number
K091216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/19/2019
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 Number10379675
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/10/2019
Initial Date FDA Received10/23/2019
Supplement Dates Manufacturer Received11/27/2019
Supplement Dates FDA Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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