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

Catalog Number 10714595

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Not Applicable (3189)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is in the process of evaluating this event.The cause for this event is unknown.

Event Description

Siemens states that during internal testing of an xprecia stride system, an engineer heard a loud pop, saw a flash behind the touchscreen, and saw a small amount of smoke with a burnt odor.The instrument was not being used for patient testing and no sampling was being performed on the stride at the time.The issue did not make the analyzer hot, no flame was visibly present, and the failure was contained within the analyzer.

Manufacturer Narrative

The analyzer was disassembled and a capacitor on the main board was visibly black which indicated failure of the capacitor.The failed capacitor would have generated the smoke and burnt odor that was seen by the operator.There was no evidence of ignition or fire.The failed capacitor was removed from the board and the analyzer was powered on with no issues.No other components were found to be damaged.

• 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: 6581308
• MDR Text Key: 75620413
• Report Number: 3002637618-2017-00082
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10714595
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• 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