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

Model Number DIMENSION EXL WITH LM

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted a siemens customer care center.Siemens remotely assisted the customer and the customer cleaned all windows and performed photometer arm alignment and milli absorbance readings (mau) offset calibration.The customer reviewed the photometer diagnostic test.Then, the customer shut down the instrument, replaced the heat torch and source lamp, checked film, and noticed the misaligned photometer and malfunctioned filter wheel.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse cleaned the windows and tested the warm air and air pressure, which recovered acceptably.Siemens further evaluated the event and concluded that the dirty windows potentially contributed to the cuvette failed photometric qc check error, which was resolved after cleaning the windows.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported to a siemens customer care center specialist that while troubleshooting a cuvette failed photometric qc check error by replacing a heat torch on the dimension exl with lm instrument, an operator observed flames and sparks.The operator's finger was reportedly slightly burned, and the operator remedied the burn by icing the finger without any further medical intervention.There are no known reports of adverse health consequences due to this event.

• 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.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18914126
• MDR Text Key: 337783316
• Report Number: 2517506-2024-00101
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 01/19/2024
• 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