FDA Adverse Event Malfunction Summary report: N

CNS-9700

MDR report key: 4173615 · Received September 10, 2014

Report

Report Number
2080783-2014-00045
Event Type
Malfunction
Date Received
September 10, 2014
Date of Event
August 14, 2014
Report Date
August 14, 2014
Manufacturer
NIHON KOHDEN CORP
Product Code
MHX
Product Problem
Yes
Report Source
Distributor report
Reporter Location
PA, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

THE CENTRAL MONITORING SYSTEM (CNS) SCREEN WENT BLANK A FEW TIMES, EACH TIME THE CUSTOMER POWERED THE SCREEN ON THEN OFF. IT CAME BACK ON BUT WOULD GO DARK AGAIN. MFR REF #:8030229-2014-00045.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
559590 CNS-9700 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP CNS-9700

Patients

Seq Age Sex Outcome Treatment
1 NI