MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT

Model Number ADVIA CENTAUR XPT

Device Problem Electro-Static Discharge (2149)

Patient Problem Electric Shock (2554)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted the siemens customer care center (ccc) to report that he sporadically felt a shock when he touched the keyboard or mouse of an advia centaur xpt instrument.As per siemens instructions, the customer halted the use of this instrument.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse replaced a touchscreen monitor, the mouse, and the keyboard on the instrument, and addressed an unrelated error on the instrument.The customer experienced no further shocks following the replacement of these parts.The instrument is performing according to specifications.Siemens is investigating the event.

Event Description

The customer reported that since the beginning of january, he sporadically felt a shock when he touched the keyboard or mouse of an advia centaur xpt instrument.The customer stated that the shock caused the monitor to temporarily go off.The customer also indicated that the mouse stopped working.The customer did not require medical intervention and has not suffered an injury due to the shock.Moreover, the customer stated that he was the only one in the lab that reported feeling the shock.The shock did not cause a mark on the customer's hand.There are no reports of sparks, smoke, or flames due to the event.The customer was wearing latex gloves when touching the mouse or keyboard.Furthermore, there were no delays in reporting patient results because the customer had an alternate instrument to process samples.There are no known reports adverse health consequences due to this event.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2022-00037 on 15-feb-2022.Additional information (28-feb-2022): siemens further investigated the issue.Siemens determined that the shock was potentially due to normal static electricity and it is possible that the shock was not related to the monitor, keyboard, or mouse assembly.The customer instrument has been returned to normal operation and there are no further occurrences of static shocks reported.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XPT
• Type of Device: ADVIA CENTAUR XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane; dublin, swords, co. ; EI
• Manufacturer Contact: douglas stanton ; 511 benedict ave; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 13538636
• MDR Text Key: 296329970
• Report Number: 2432235-2022-00037
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: 00630414596914
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XPT
• Device Catalogue Number: 10711433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2020
• 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
• Patient Sex: Male