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

Catalog Number 10379675

Device Problems Smoking (1585); Device Displays Incorrect Message (2591); Sparking (2595)

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

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens is in process of investigating customer returned materials.The cause for the event is unknown at this moment.

Event Description

Customer reported that connector base started smoking and sparking and it caused the instrument to give error (e02) code.There was no report of injury due to this event.

Manufacturer Narrative

Siemens hsc team investigated customer returned instrument and root cause was found to be defective choke components on the main board.This is a known issue, and corrective action has been implemented from serial # (b)(4).Resolution was alternative supplier of component.No further investigation is required.Customer was sent a replacement instrument.Upon follow up, customer confirmed that the new instrument has been running well, and she needs nothing else.

• 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: 5131569
• MDR Text Key: 27967322
• Report Number: 1217157-2015-00143
• 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
• Type of Report: Followup
• Report Date: 11/16/2015

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: No Information
• 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: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1