MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC SYSTEM

Model Number	BN PROSPEC SYSTEM
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the site and confirmed that the bn prospec power supply had failed.The cse replaced the power supply, after which the system returned to normal operation.The cause of the event was the power supply failure.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
After the customer turned on their bn prospec system, the system made a banging noise, after which smoke was emitted from the system and vapor filled the room.The system was powered down and was taken out of operation.The system was down for one day and there was a delay in patient testing of one day.There are no known reports of adverse health consequences due to this event.

• Brand Name: BN PROSPEC SYSTEM
• Common Device Name: BN PROSPEC 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: 14523926
• Report Number: 9610806-2022-00039
• Device Sequence Number: 5604455
• Product Code: JZW
• UDI-Device Identifier: 00630414002736
• UDI-Public: 00630414002736
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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: BN PROSPEC SYSTEM
• Device Catalogue Number: 10465217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (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