MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS

Catalog Number 10282611

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Customer indicated that they powered off the instrument, cleaned all urine from the printer, removed printer and cleaned printer contacts and ribbon holder.Customer has disabled the printer option.The customer was provided with a new part for the printer.The event has occurred due to an operator error.

Event Description

Customer said they spilled urine on the printer and the printer no longer works.Customer saw a puff of smoke when they tried to print.Customer confirmed that there was no injury due to this event.

• 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 anberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5957161
• MDR Text Key: 54997932
• Report Number: 1217157-2016-00106
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 09/16/2016

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: Medical Technologist
• Device Catalogue Number: 10282611
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/16/2016
• 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: Reuse
• Patient Sequence Number: 1