MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201; CENTRAL MONITOR SYSTEM

Device Problems Failure To Service (1563); Inadequate Service (1564)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Technical support had the customer do a hard restart and the cns started into windows and opened cns software.Raid check checked for errors (not degraded).The customer reports cns has not been restarted in over a year, so our technical support instructed them that the cns needs to be restarted once every 90 days as a part of the periodic maintenance.This is a maintenance issue that is stated in the service manual.

• Brand Name: CNS-6201
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; JA
• Manufacturer Contact: 1-31-4 nishiochia, shinjuku-ku; tokyo 161-8-560 ; 7050350
• MDR Report Key: 4226360
• MDR Text Key: 18066988
• Report Number: 8030229-2014-00074
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1