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

Model Number CNS-6201A

Device Problems Electrical Power Problem (2925); Installation-Related Problem (2965); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The emergency room and intensive care unit nurse manager reported that the central nurse's station (cns) was not booting into the cns software after a fifth power outage occurrence.The cns was stuck on the splash screen of the software.Nihon kohden technical support (nk ts) advised the customer to ensure that the ethernet cable was plugged in, and asked him to unplug and re-plug the cord.Nk ts asked the customer to ensure the blackbox was turned on.The cns still would not boot, and was not displaying any error messages.Nk ts had the customer remove the initial hard disk drive (hdd) that was in slot zero, and the unit booted up.The customer is going to purchase a new hdd from customer service.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 emergency room and intensive care unit nurse manager reported that the central nurse's station (cns) was not booting into the cns software after a fifth power outage occurrence.The cns was stuck on the splash screen of the software.

Manufacturer Narrative

Details of complaint: the emergency room and intensive care unit nurse manager reported that the central nurse's station (cns) was not booting into the cns software after a fifth power outage occurrence.The cns was stuck on the splash screen of the software.Nihon kohden technical support (nk ts) advised the customer to ensure that the ethernet cable was plugged in and asked him to unplug and plug the cable back in.Nk ts asked the customer to ensure the blackbox was powered on.The cns would still not boot and was not displaying error messages.Nk ts had the customer remove the initial hard disk drive (hdd) that was in slot 0, and the unit booted up.The customer planned to purchase a new hdd to resolve the issue.Service requested / performed: troubleshooting.Investigation summary: the root cause of the issue was found to be corruption of the hard drive due to multiple power outages.Sudden power outages, power surges, abnormal shutdowns, viruses, complete system crashes, and updating errors could all cause the corruption of files.The overall risk of this event is medium.The reported issue does not require further investigation through capa process since the issue was caused due to multiple power outages which is outside of nk circle of influence.

Event Description

The emergency room and intensive care unit nurse manager reported that the central nurse's station (cns) was not booting into the cns software after a fifth power outage occurrence.The cns was stuck on the splash screen of the software.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 9533648
• MDR Text Key: 200825525
• Report Number: 8030229-2019-00747
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/30/2019,11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2019
• Distributor Facility Aware Date: 12/03/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• 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
• Treatment: NI.; NI.