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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 10379680
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2014
Event Type  malfunction  
Event Description
Customer reported that they received broken power supply adaptor.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer has been provided with new power cord.The cause for the broken power cord is unknown.
 
Manufacturer Narrative
The original equipment manufacturer (oem) of these power supplies has identified two root causes for the damaged power supply adaptors.1.The incorrect torque setting was selected by the production operator for the screws used to secure the power supply adaptor housings together.2.Mineral oil was found on the screws used to secure the housings together.The oil is used during the machining process during the production of the screws and was not removed by the screw supplier.These two root causes resulted in a combination of mechanical and chemical stress which led to the cracking of the screw pillars inside the housing top of the power supply adaptor.Siemens issued an urgent field safety notice (31983 rev.A) to notify all affected siemens customers.
 
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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 Key4102882
MDR Text Key4758773
Report Number1217157-2014-00132
Device Sequence Number1
Product Code JIL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K091216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/01/2014
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 Number10379680
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/25/2014
Initial Date FDA Received09/19/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/25/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Initial
Removal/Correction Number1217157-09-22-2014-001-R
Patient Sequence Number1
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