MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+; CT STATUS+

Catalog Number 10379675

Device Problems Nonstandard Device (1420); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Customer reported that instrument was intermittently turning off.There was no report of injury due to this event.

Manufacturer Narrative

Customer has been provided with urgent field safety notice and new power cord.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) in september 2014 to notify all affected siemens customers.

• 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 Key: 4396452
• MDR Text Key: 5303894
• Report Number: 1217157-2015-00002
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10379675
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1217157-09-22-2014-001-R
• Patient Sequence Number: 1