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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+
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SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEK STATUS+ Back to Search Results
Catalog Number 10376324
Device Problem Smoking (1585)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2020
Event Type  malfunction  
Manufacturer Narrative
The customer has been advised not to use the connect base and a replacement has been sent.Siemens has requested that the customer return the instrument for investigation, however it has not yet been received.The cause of this event is unknown.
 
Event Description
The customer reported that their connect platform gave off a small puff of smoke and no longer powers on the instrument.The instrument powers on with no issues when connected directly to the power supply.There was no report of injury due to this event.
 
Manufacturer Narrative
The customer returned the instrument for further investigation.The clinitek status+ was functioning but the connect base was damaged due to failure of t1 component.Investigation revealed that a component manufacturing issue with choke t1 was identified and fixed through an engineering change notice in 2009.The failure of these chokes does not pose a safety risk as the plastics making up the connect base are 94v0.The customer was sent a replacement connect base, and they are operational.
 
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Brand Name
CLINITEK STATUS+
Type of Device
CLINITEK STATUS+
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict avenue
tarrytown, ny
MDR Report Key10367220
MDR Text Key201683906
Report Number3002637618-2020-00040
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10376324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2020
Date Manufacturer Received09/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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