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

Catalog Number 10379675

Device Problems Nonstandard Device (1420); Loss of Power (1475); Device Stops Intermittently (1599)

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

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens customer service engineer (cse) asked customer to check manufacture date code on side of power supply.It was #51130.Customer indicated that they did receive information (ufsn) about the recall for these long time ago and they thought they had confirmed date range on all but this one had been missed.Customer had been instructed to discard the faulty power supply.Customer has been sent replacement power supply.They have confirmed new power supply received and working with no issues.The original equipment manufacturer (oem) of these power supplies has identified following root causes for the damaged power supply adaptors.The incorrect torque setting was selected by the production operator for the screws used to secure the power supply adaptor housings together.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 reported instrument shutting itself off intermittently.Customer had verified outlet was good, checked power at each end of power supply cables, unplugged and replugged.Customer indicated that power came up the shortly and turned itself off.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: 5117193
• MDR Text Key: 27474822
• Report Number: 1217157-2015-00141
• 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: Biomedical Engineer
• Remedial Action: Recall
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-0081-2015
• Patient Sequence Number: 1