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

Model Number CNS-6201A

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reports that their central nurse's station (cns) is not booting up.No harm or injury was reported.The customer will need to replace the existing hdd's in order to mitigate the issue.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reports that their central nurse's station (cns) is not booting up.No harm or injury was reported.The customer will need to replace the existing hdd's in order to mitigate the issue.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was not booting up.The customer ordered replacement hdds to resolve the issue.No patient harm was reported.Investigation summary: during the boot up sequence, the operating system and the cns application from the hard drive is loaded.The cns cannot boot up when the hard drives have failed.Two new hard drives were issued to the customer to fix the problem.Service history for this serial number shows this is an isolated incident.Boot up issue overview boot up failure, including boot looping, booting into bios, failure to load the cns application, and failure to complete the boot up cycle are the result of hard drive failures.Hard drive failures are caused by environmental factors, maintenance factors, or the hard drive has reached the end of its lifespan (2 years).The cns device requires regular maintenance, as outlined in the operator's manual.When stored for an extended period of time, operation checks should be performed.In short, the symptoms of the device not being able to boot up is related to its internal hard drives.This is indicative of a device needing maintenance and/or service.

Event Description

The customer reported that the central nurse's station (cns) was not booting up.No harm or injury was reported.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14048687
• MDR Text Key: 289022807
• Report Number: 8030229-2022-02707
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1