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	06/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that while troubleshooting a barcode label printer on the atellica sample handler prime, the customer observed a spark when reconnecting the printer power cord.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse straightened the plug in the barcode printer and secured the power connection.The cse powered up the barcode printer, tested it, and determined it was operational.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that the barcode printer of the atellica sample handler prime stopped printing and the customer was unable to print a barcode.As a result, the customer unplugged the printer.When the customer attempted to reconnect the printer, the customer reportedly observed a spark.There are no known reports of flames, smoke, nor adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2024-00148 on 03-jul-2024.Additional information (03-jul-2024): siemens further evaluated the event and determined that the operator observed a spark while reconnecting the power cord to power on the printer because the operator forced the power cord in, caused one of the blades to bend, and triggered a spark.Additionally, the power cord could not be fully seated in the receptacle.As mentioned in the initial report, the cse addressed this event by straightening the plug and powering on the printer.Based on the evaluation, siemens concluded that a use error contributed to the event.The investigation findings and investigation conclusions codes in section h6 were 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 ; siemens healthcare diagnostics; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 19671072
• Report Number: 2432235-2024-00148
• Device Sequence Number: 3176104
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 630414002439
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/17/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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