FDA Adverse Event Malfunction Summary report: N

CNS-6201

MDR report key: 4922423 · Received July 15, 2015

Report

Report Number
2080783-2015-00173
Event Type
Malfunction
Date Received
July 15, 2015
Date of Event
June 20, 2015
Report Date
June 20, 2015
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 CUSTOMER STATED THAT THE CENTRAL MONITORING SYSTEM (CNS) DISPLAY WENT BLACK. REFERENCE MFR # 8030229-2015-00173.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
460589 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP. CNS-6201

Patients

Seq Age Sex Outcome Treatment
1 NI