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

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

List of affected power supply serial#s: (b)(4).Customer was provided with new power supply cords.Customer had been requested to provide information on ufsn three times, customer has not responded yet.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 (31983 rev.A) in september 2014 to notify all affected siemens customers.

Event Description

Customer discovered that they have powercords affected by the urgent field safety notice 31983 rev.A.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: 5232439
• MDR Text Key: 31462015
• Report Number: 1217157-2015-00171
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-0081-2015
• Patient Sequence Number: 1