MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME

Model Number ATELLICA SAMPLE HANDLER PRIME

Device Problems Circuit Failure (1089); Smoking (1585); Power Problem (3010)

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

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

Smoke emitted from the interconnect printed circuit board (pcb) and power supply assembly on an atellica sample handler prime when the siemens customer service engineer (cse) installed the instrument and powered on the system.The cse shut down the system, turned off all breakers, and unplugged the power cable.Next, the cse manually removed calibrators and quality controls (qcs) from the calibrator-control storage (ccs) and stored them in a refrigerator.During a subsequent visit, the cse installed a new power supply assembly and an interconnect pcb.Then, the cse installed a new device controller module (dcm) assembly.Next, the cse shutdown the instrument through the user interface (ui), turned the power on for the sample handler module manager (mm), and restarted the process center computer (pcc) successfully.An auto check was successfully performed.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A siemens customer service engineer observed smoke from the interconnect printed circuit board (pcb) and power supply assembly on an atellica sample handler prime during installation, shortly after the powering on the system.There were no visible flames associated with the event.The instrument was shut down with all circuit breakers powered off and power cable disconnected.There are no known reports of adverse health consequences nor delay in reporting results due to the event.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2023-00252 with the fda on 12-sep-2023.Additional information (26-sep-2023): siemens further evaluated the customer service engineer¿s (cse) actions at the time that smoke and a burning smell emitted from the instrument.Siemens concluded that the cse either incorrectly installed the sample handler (sh) interconnect board, leading to a short with the wiring or the trace on the board itself, or the service spare sh interconnect board malfunctioned out of the box, which contributed to the incident.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Type of Device: ATELLICA SAMPLE HANDLER PRIME
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; flanders NJ 07836
• Manufacturer Contact: douglas stanton ; 511 benedict avenue; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 17732588
• MDR Text Key: 323225300
• Report Number: 2432235-2023-00252
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 00630414002439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161954
• 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,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA SAMPLE HANDLER PRIME
• Device Catalogue Number: 11069001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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