MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number DIMENSION EXL WITH LM

Device Problem Smoking (1585)

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

Event Date 03/10/2024

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that the reagent management system (rms) on the dimension exl with lm instrument, did not power up while processing quality control (qc) and observed smoke.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse found that the instrument was turned off, checked electrical outlet for rms and main instrument, rebooted instrument, and rms, only instrument booted up.Then, the cse checked all connections, rms, uninterrupted power supply (ups) was powered on and then shuts off, removed load from ups, de configured rms, turned on main unit, removed all flexes and installed all new flexes, ran system checks.Next, the cse replaced batteries in ups on rms, checked circuit breaker fuses, ups in line fuse, power cord and powered on wall outlet.Later, the cse removed the connections from line output for rms ups, unplugged the rms ups from inlet power line, bypassed the ups, reconfigured rms in system set up screen, removed all rms reagent from inventory, primed instrument 10 times and ran system checks, which recovered acceptably.The cause of the incident is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported that the reagent management system (rms) on the dimension exl with lm instrument did not power up while processing quality control (qc) and observed smoke.The customer stated that there were no visible flames associated with the event.There are no known reports of adverse health consequences due to the incident.

Manufacturer Narrative

Siemens filed the initial mdr 2517506-2024-00112 on 28-mar-2024.Additional information (01-apr-2024): in addition to the service actions mentioned in the initial report, a siemens customer service engineer (cse) replaced the circuit breaker, power unit and uninterrupted power supply (ups).Siemens further evaluated the event and concluded that the failure of the electrical components was due to power issues in the lab caused by high winds during a storm.The investigation conclusion in section h6 was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 18995306
• MDR Text Key: 338892839
• Report Number: 2517506-2024-00112
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10486890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• 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