inforMED
MalfunctionJZW

BN PROSPEC SYSTEM

Received May 27, 2022 · Event occurred May 6, 2022

Report 9610806-2022-00039 · MDR key 14523926

Device

Generic name

Bn Prospec System

Model number

BN PROSPEC SYSTEM

Catalog number

10465217

Product problems

  • Smoking
  • Smoking

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

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.

Description of Event or Problem

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.