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

Model Number ATELLICA CH CLEANER

Device Problem Leak/Splash (1354)

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

Event Date 08/21/2020

Event Type  malfunction  

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 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
• Type of Device: ATELLICA CH CLEANER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 50 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytowm, NY 10591 ; 9145242740
• MDR Report Key: 10523223
• MDR Text Key: 226579520
• Report Number: 2432235-2020-00380
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414595757
• UDI-Public: 00630414595757
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K151767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/11/2020
• 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