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

Catalog Number 10379680

Device Problems Break (1069); Nonstandard Device (1420); Loss of Power (1475)

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

Event Date 10/11/2014

Event Type  malfunction  

Event Description

Customer reported that they received broken power supply.Customer reported that instrument lost power during medical examination.Customer also reported that power adaptor was opened and the electrical parts were in contact.There was no report of injury due to this event.

Manufacturer Narrative

Customer indicated that they replaced power supply and since then they have had no issue with power supply.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.

• 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: 4223434
• MDR Text Key: 5076041
• Report Number: 1217157-2014-00168
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10379680
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1217157-09-22-2014-001-R
• Patient Sequence Number: 1