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

Catalog Number 10379675

Device Problems Nonstandard Device (1420); Defective Device (2588)

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

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

Customer has been instructed to discard the power supply according to local regulations and not to use it again.An ufsn was provided to the customer.Customer confirmed that they were not adversely affected by defective power supply.Customer will be provided with a new power supply.The original equipment manufacturer (oem) of these power supplies has identified following 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.Manufacturing and inspection procedures have been revised at the manufacturer of the power supplies to address this issue.These corrective actions were finalized and implemented in june 2014.Siemens issued an urgent field safety notice ((b)(4)) in september 2014 to notify all affected siemens customers.

Event Description

Customer reported that they received defective power supply.There was no report of injury due to this event.

• 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: 4950416
• MDR Text Key: 24651738
• Report Number: 1217157-2015-00109
• 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: company representative,user f
• Reporter Occupation: Medical Assistant
• Remedial Action: Recall
• Report Date: 07/01/2015

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 Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0081-2015
• Patient Sequence Number: 1