MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA CH CLEANER

Model Number	ATELLICA CH CLEANER
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The customer correctly stored the atellica ch cleaner upright and in its appropriate box as per the atellica ch system fluids instruction for use (ifu).The customer provided siemens a picture of the cap of the atellica ch cleaner where a crack and separation of the cap was visible.The cracked cap caused the atellica ch cleaner to leak out.The cause of the cracked cap is unknown, however, damage during shipping and handling cannot be ruled out as a potential cause of the cracked cap.The atellica ch cleaner is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Atellica ch cleaner leaked onto the customer's skin and pants after removing the cleaner from its plastic packaging.The customer washed their skin after exposure.No further medical treatment was necessary.There are no reports of adverse health consequences due to this event.

• Brand Name: ATELLICA CH CLEANER
• Common Device Name: ATELLICA CH CLEANER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 10523223
• Report Number: 2432235-2020-00380
• Device Sequence Number: 16923834
• Product Code: JJE
• UDI-Device Identifier: 00630414595757
• UDI-Public: 00630414595757
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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 Expiration Date: 02/06/2021
• Device Model Number: ATELLICA CH CLEANER
• Device Catalogue Number: 11099303
• Device Lot Number: 0000127252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1