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

Model Number ATELLICA SAMPLE HANDLER PRIME

Device Problem Sparking (2595)

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

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that after opening and/or shutting drawer 2 on an atellica sample handler prime, the wire underneath was trapped and sparking.The customer removed all quality control materials and performed controlled shut down of the sample handler primary (sp) and sample handler additional (sa).A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and noted that the harness was cut by drawer sliding in and out.The cse removed power to the gantry, from the control storage area and gripper amplifier, replaced the primary control assembly (pca) drawer vision system (dvs) photo interrupter board and restored power, ran dvs drawer alignment and drawer griper to drawer alignment and replaced damaged harness.Siemens evaluated the event and concluded that the event was resolved by the replacement of the damaged harness.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported that after opening and/or shutting drawer 2 on an atellica sample handler prime, the wire underneath was trapped and sparking.The customer stopped the instrument and closed the drawer.There were no visible flames or smoke due to the incident.There was no injury reported.There are no known reports of adverse health consequences due to the event.

• 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.; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 19004470
• MDR Text Key: 338916377
• Report Number: 2432235-2024-00061
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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