MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

Model Number BCS XP SYSTEM

Device Problem Smoking (1585)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site for another issue, and the smoking incident occurred as the cse was replacing a 24 volt fuse on the bcs xp system.The cse observed that the smoke was emitting from two circuit boards on the system (pca hc11 and pca mpos).The cse replaced the two affected boards, which resolved the issue.The cause of the event was the two defective circuit boards.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Visible smoke was emitted from the customer's bcs xp system after a siemens customer service engineer (cse) replaced a 24 volt fuse on the system and attempted to turn on the system.The system had been down for three days prior to this event.There was no delay in testing as the customer had a backup system to process samples.There are no known reports of adverse health consequences due to this event.

• Brand Name: BCS XP SYSTEM
• Type of Device: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 12108049
• MDR Text Key: 259639321
• Report Number: 9610806-2021-00051
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10470625
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• 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