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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2432235-2024-00061
• Device Sequence Number: 8446208
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 00630414002439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown