MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300

Model Number ATELLICA IM 1300

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that smoke potentially emitted from the atellica im 1300 analyzer.The customer subsequently powered off the analyzer.This report is being filed in an abundance of caution as the customer was unsure whether smoke or dust emitted from the analyzer.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected analyzer, replaced wash ring heater assembly, rebooted the analyzer, and determined that the instrument temperature was within acceptable range.Then, the customer ran quality control (qc), which recovered acceptably.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer indicated that smoke or dust emitted from an atellica im 1300 analyzer.They were unsure if it was smoke or dust and stated that the top of the analyzer was hot.Hence, this report was filed in an abundance of caution.The customer subsequently powered off the analyzer.There are no known reports of injury, impact to patient testing, or adverse health consequences due to the incident.

• Brand Name: ATELLICA IM 1300
• Type of Device: ATELLICA IM 1300
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin 10591 ; EI 10591
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18686509
• MDR Text Key: 336402805
• Report Number: 2432235-2024-00035
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA IM 1300
• Device Catalogue Number: 11066001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Date Device Manufactured: 08/05/2019
• 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