MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS XPRECIA STRIDE COAGULATION SYSTEM

Catalog Number 10714595

Device Problems Electrical /Electronic Property Problem (1198); Smoking (1585); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

It is stated in the complaint report that another instrument is being sent to the customer in exchange for the defective one.Once the defective instrument is received, the device evaluation will begin.

Event Description

The customer reported that the xprecia stride didn't switch on and that smoke was seen coming from the instrument.There was no report of injury due to this event.

Manufacturer Narrative

The analyzer was disassembled and electrical engineering observed a capacitor that had failed.When the analyzer was removed from the xprecia stride box, there was a 'burnt' odor.External review of the analyzer showed no evidence of damage.Upon disassembly, a capacitor on the main board was found to have failed.The heat from the capacitor would have generated the smoke seen by the customer, but there is no evidence of ignition or fire.Additional testing was performed to determine if the issue was related to a faulty component on the board or the capacitor itself.The defective capacitor was replaced with a new one and the instrument booted up and operates with no issues.There appears to be no issue with the board, just the one capacitor.The issue appears to be isolated to just this one instrument.

• Brand Name: XPRECIA STRIDE COAGULATION SYSTEM
• Type of Device: XPRECIA STRIDE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD.; plot 87 lebuhraya kampung jawa; bayan lepas pulau pinang, 11900 ; MY 11900
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6139286
• MDR Text Key: 61548634
• Report Number: 3002637618-2016-00158
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10714595
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• 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: N
• Patient Sequence Number: 1