MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ATLAS

Catalog Number 10319270

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The customer unplugged the instrument and no longer saw or smelled smoke.Siemens service has been dispatched.The service report is pending.The cause of this event is unknown.

Event Description

The customer stated that a small amount of smoke was seen coming from the clinitek atlas analyzer.There was no report of injury due to this event.

Manufacturer Narrative

Siemens service went onsite and replaced the sample handler, setup the rack handler, calibrated the instrument and ran controls.The system was operational upon departure.

• Brand Name: CLINITEK ATLAS
• Type of Device: CLINITEK ATLAS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7534373
• MDR Text Key: 108994019
• Report Number: 3002637618-2018-00062
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• PMA/PMN Number: K932674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10319270
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1