FDA Adverse Event Malfunction Summary report: N

CNS-6201

MDR report key: 4040976 · Received June 11, 2014

Report

Report Number
8030229-2014-00006
Event Type
Malfunction
Date Received
June 11, 2014
Manufacturer
NIHON KOHDEN CORP.
Product Code
MHX
PMA / PMN Number
K102376
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

UNIT CAME IN FOR REPAIR, THE HARD DRIVE WAS REPLACED AND UNIT WAS RETURNED TO THE CUSTOMER.

Description of Event or Problem · 1

(B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
345920 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP.

Patients

Seq Age Sex Outcome Treatment
1