MADSEN ACCUSCREEN

Additional Manufacturer Narrative

FINAL REPORT (REF NATUS COMPLAINT (B)(4)). CALLER REPORTS MADSEN ACCUSCREEN FAILED TO RESET AFTER DATA WAS TRANSFERRED TO SYSTEM SOFTWARE. LOG IN SCREEN DIDN'T APPEAR AND RISK FACTOR QUESTIONS WERE INCOMPLETE ON THE SCREEN. NO INJURIES REPORTED. WE REACHED OUT TO CUSTOMER FOR MORE INFORMATION AND THEY HAD NO KNOWLEDGE OF COMPLAINT. THEY INVESTIGATED FURTHER INTERNALLY AND DO NOT KNOW WHERE THE COMPLAINT CAME FROM. THE DEVICE IN QUESTION FUNCTIONS CORRECTLY AND THEY DO NOT WISH TO RETURN IT OR PURSUE THE COMPLAINT. COMPLAINT CLOSED. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT) THE CURRENT RISK FILE DOC- (B)(4) IDENTIFIES THIS ISSUE HARM - DELAY IN USE OF THE SYSTEM OR TREATMENT. CAUSE- SYSTEM DOES NOT WORK DUE TO INCORRECT SOFTWARE SETUP (E.G. WRONG PASSWORD, INSUFFICIENT ACCESS RIGHTS, ETC.) SEVERITY- NEGLIGIBLE (0). RISK LEVEL- MINOR (0). THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED.

Additional Manufacturer Narrative

INITIAL REPORT (REF NATUS COMPLAINT (B)(4)). CALLER REPORTS MADSEN ACCUSCREEN FAILED TO RESET AFTER DATA WAS TRANSFERRED TO SYSTEM SOFTWARE. LOG IN SCREEN DIDN'T APPEAR AND RISK FACTOR QUESTIONS WERE INCOMPLETE ON THE SCREEN. NO INJURIES REPORTED. CUSTOMER WILL BE ADVISED TO RETURN THE DEVICE FOR EVALUATION.

Description of Event or Problem

MADSEN ACCUSCREEN FAILED TO RESET AFTER DATA WAS TRANSFERRED TO SYSTEM SOFTWARE. LOG IN SCREEN DIDN'T APPEAR AND RISK FACTOR QUESTIONS WERE INCOMPLETE ON THE SCREEN.