MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK STATUS+ USA

Catalog Number 10379675

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Not Applicable (3189)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

The customer returned the instrument for investigation as well as the power supply.Investigation of the instrument determined that there was a failure of d16 on the main pcb.D16 is the overvoltage protector diode, which blows if the voltage applied to instrument is too high.The power supply was tested and determined to be performing as expected.The root cause of the failure is not able to be determined.

Event Description

The customer reported smoke coming from the back of the clinitek status+.There was no report of injury due to this event.

• Brand Name: CLINITEK STATUS+ USA
• Type of Device: CLINITEK STATUS+
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 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: 6465248
• MDR Text Key: 72338408
• Report Number: 3002637618-2017-00064
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2017

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: Health Professional
• Device Catalogue Number: 10379675
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1