MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM; INSTRUMENT, COAGULATION, AUTOMATED

Model Number	N/A
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) to report the observation of a bcs xp system (sn# (b)(6) ) which was not in communication with the central processing unit (cpu).A siemens customer service engineer (cse) was dispatched to the customer site.During troubleshooting, a circuit board blew a fuse and smoke was visible.After observing the smoke, the cse replaced the printed circuit assembly (pca).It was found that smn 11241849 pca flash v4 (lamp driver board) failed, which is a high voltage electronic board.The failure of the pca flash v4 possibly caused the cascade of failures such as the blown fuses, failure of the pca mpos and lamp.These parts are contained within the instrument and not accessible to the customer.Parts were replaced and the system was returned to normal operation.The customer is operational, and the reported issue is resolved by routine service part replacement.The bcs xp system is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.
Event or Problem Description
The customer reported the observation of a bcs xp system (sn#(b)(6)) which was not in communication with the central processing unit (cpu).During troubleshooting by the siemens customer service engineer (cse), the sample transfer printed circuit board (pcb) began to smoke before blowing a fuse.The cse found 4 fuses were blown.No harm to the user was alleged due to this event.No erroneous patient results were generated due to this event.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: BCS XP SYSTEM
• Common Device Name: INSTRUMENT, COAGULATION, AUTOMATED
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; am kronberger hang 3; registration number 3003601075; schwalbach 65824 ; GM 65824
• Manufacturer Contact: karen confort ; 333 coney street; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 20032562
• Report Number: 9610806-2024-00025
• Device Sequence Number: 6423790
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: (01)00630414945514
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10459330
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown