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	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that when an operator pulled a drawer forward on an atellica sample handler prime, the operator observed sparks.The operator was able to close the drawer without any issue.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument and determined that the sample handler (sh) drawer 2 light barrier sensor printed circuit board (pcb) malfunctioned.The cse replaced pcb board, aligned the drawer vision system (dvs) and ran auto check, which recovered acceptably.In a subsequent visit, the cse also replaced the left and right sliding rails of a drawer and successfully aligned the dvs.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
The customer reported that after loading a sample on the atellica sample handler prime, an operator opened a drawer and determined it was stuck midway.The customer also reported that the operator observed sparks when the operator tried to pull the drawer forward.The operator did not experience an electric shock due to the event.The operator was able to close the drawer without any issue.There are no known reports of visible flames, smoke, nor adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00075 on 18-apr-2024.Additional information (21-jun-2024): siemens further evaluated the event and determined that an obstruction from the encoder strip metal rubbing against the board within the drawer or a power cabling issue potentially contributed to the event.The investigation conclusion code in section h6 was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 19139802
• Report Number: 2432235-2024-00075
• Device Sequence Number: 21191760
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 00630414002439
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 07/08/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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