MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number 10484765

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Not Applicable (3189)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the printer to be returned for investigation.The customer stated that there was no damage to any property other than the printer.The cause of this event is unknown.

Event Description

The customer reported that smoke was seen coming from the printer and a burn was seen on the printer paper.There was no report of injury due to this event.

Manufacturer Narrative

Siemens evaluated the returned printer and the conclusion is that the customer issue with the printer was reproduced and the failure was attributed to the electronics shorting out as a result of a fluid spill.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CLINITEK ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): KIMBALL ELECTRONICS; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne, 62080 ; PL 62080
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 6680200
• MDR Text Key: 78789683
• Report Number: 3002637618-2017-00106
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

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: Nurse
• Device Catalogue Number: 10484765
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 09/19/2017
• Supplement Dates FDA Received: 09/27/2017
• 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