MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER

Model Number ATELLICA CH 930 ANALYZER

Device Problems Circuit Failure (1089); Smoking (1585); Sparking (2595); Power Problem (3010)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

An outside the united states (ous) customer contacted a siemens technical applications specialist (tas).A siemens personnel was dispatched to customer¿s site.The siemens personnel removed the back panel of the atellica ch, observed a small puff of smoke emitted from the inside of the panel, found a burnt-out fuse, and the fuse housing was hot.Then, the siemens personnel shut down the system and took off all reagents and put parafilm on them.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse inspected the system and determined the damage was concentrated on the direct current ¿ device controller module 2 (dc-dcm2) board, where fuse 1 (f1) and fuse 2 (f2) were burnt.The cse inspected the wire harness, the sample arm, mixer fluidics heater and lysing agent cooling, but no abnormities were found.The cse checked the resistance of the mixer fluidics heater, lysing agent peltier cooler and their related thermistors, which had resistances equal to the expected levels, except for the peltier cooler on the lysing agent station.The cse replaced f1 and f2, turned on the power, and smoke came out from dc-dcm2.The cse removed connector 1 and connector 2 (oc1&oc2) at the back of dc-dcm2, turned on the power, and smoke was observed during boot.Then, the cse opened the dc-dcm2 cover and found a burned circuit board.In a subsequent visit, the cse replaced the dc-dcm2, the mixer fluid heater, and as a precaution the hybrid device controller module (cn) 14 and 15.Temporarily, the cse disconnected the lysing agent cooler, the thermal electric device (ted), and the thermistor.The system was successfully rebooted without incident.The cse successfully performed the daily maintenance.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A siemens customer service engineer observed smoke from the fuses on the direct current ¿ device controller module 2 (dc dcm2) of an atellica ch 930 instrument during instrument installation.Shortly after the power was applied, fuse 1 (f1) and fuse 2 (f2) on dc-dcm2 blew and sparks were observed.There are no known reports of adverse health consequences due to the event.

• Brand Name: ATELLICA CH 930 ANALYZER
• Type of Device: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; flanders NJ 07836
• Manufacturer Contact: douglas stanton ; 511 benedict ave.; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 17749479
• MDR Text Key: 323695273
• Report Number: 2432235-2023-00253
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: 630414002163
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA CH 930 ANALYZER
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Date Device Manufactured: 04/19/2023
• 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