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

Model Number	BCS XP SYSTEM
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that when the uninterruptible power supply (ups) for the customer's bcs xp system was powered on with the bcs xp system connected, the ups sparked and emitted a burning smell.A siemens customer service engineer (cse) was dispatched to the site.During the site visit, the cse found no evidence of smoke or burning from the bcs xp system or the ups.When the cse attempted to power on the ups the ups failed to power on.The cse replaced the ups and the bcs xp system powered up normally and was returned to operation.The cause of the spark emitted by the instrument was potentially due to the malfunction of the ups.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A customer reported that when the uninterruptable power supply (ups) for their bcs xp system was powered on with the bcs xp system connected, the ups sparked and emitted a burning smell.The customer unplugged the ups from the ac outlet and powered off the bcs xp system.There are no reports of patient intervention or adverse health consequences due to this event.

• Brand Name: BCS XP SYSTEM
• Common Device Name: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 9278803
• Report Number: 9610806-2019-00081
• Device Sequence Number: 13989661
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K970431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1