MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA DECAPPER

Model Number ATELLICA DECAPPER

Device Problem Electro-Static Discharge (2149)

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

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse), within the united states, felt a shock from the atellica decapper when reaching into the cap waste bin for caps.The cse checked the resistance to ground, in ohms, on the decapper and found all rails supporting the waste bin had less than 10 ohms of resistance to ground.The cse did not receive any medical treatment at the time of the event.Siemens evaluated the decapper and determined that it was working as designed and has had no additional errors.The customer was advised that no one should be reaching into the plastic waste bin of the decapper under any circumstance.Operators should remove the bin and empty it by turning it upside down as per the online help instructions.The customer was advised that it was acceptable to continue using the decapper.A potential contributing factor to the electric shock is static build up.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

Event Description

Siemens customer service engineer (cse) felt a shock from the atellica decapper when reaching into the cap waste bin for caps.The cse was removing their arm from the waste bin and noted arcing from the waste bin to their hand.The cse was wearing gloves at the time of the event.The cse did not require medical intervention and has not suffered an injury due to the shock.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ATELLICA DECAPPER
• Type of Device: ATELLICA DECAPPER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; registration # 2432235; tarrytown NY 10591
• Manufacturer (Section G): SANMINA MEXICO; carretera chapala-guadalajara; 45640 tlajomulco de zuniga; jalisco, ; MX
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 16505724
• MDR Text Key: 310963109
• Report Number: 2517506-2023-00084
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA DECAPPER
• Device Catalogue Number: 11069400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male