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

Model Number CNS-6201A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 03/29/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) crashed and was showing a blue screen on it.The bme tried to reboot the cns, but it is stuck in bios.No patient harm was reported.Nihon kohden technician advised the bme that it sounded like the harddrives had failed and needs to be returned to nihon kohden for service.The bme is returning the cns to nihon kohden for evaluation and service.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) crashed and was showing a blue screen on it.The bme tried to reboot the cns, but it is stuck in bios.No patient harm was reported.Nihon kohden technician advised the bme that it sounded like the hard drives had failed and needs to be returned to nihon kohden for service.The bme is returning the cns to nihon kohden for evaluation and 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.Additional device information: concomitant medical device: the following device(s) were used in conjunction with the cns: bsms: model #: mu-631ra.Serial #: (b)(4).Device manufacturer data: 01/01/2017.Unique identifier (udi) #: (b)(4).

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) crashed and was showing a blue screen on it.The bme tried to reboot the cns, but it is stuck in bios.No patient harm was reported.Nihon kohden technician advised the bme that it sounded like the hard drives had failed and needs to be returned to nihon kohden for service.The bme is returning the cns to nihon kohden for evaluation and service.Service requested/performed: device was cleaned and decontaminated by nihon kohden america repair center (nka rc).The model, serial number and all labels were verified.No physical damage was noticed.On rc evaluation, the reported problem was duplicated.The hard drives were recognized to be degraded and were replaced.Nka rc restarted the central nurse station (cns) and it booted up with software version 03-40 properly with 2 screens displayed which resolved the issue.The unit was tested per the operator/service manual and operated within manufacturer's specifications and was shipped back to the customer.Investigation summary: investigation determined the issue poses a medium risk.Investigation of the reported issue found the device was put into service on 07/30/2017.Approximate age of the device at the time of malfunction was 4.5 years.The root cause of the cns reboot to be due to end of useful life of the hard drive(s).Hard drives are routine service component, it is expected to be replaced periodically or as indicated.This is the normal functioning of the device and not a devitation from its intended performance.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: bsms: model #: mu-631ra serial #: (b)(6).Device manufacturer data: 01/01/2017.Unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) crashed and was showing a blue screen on it.The bme tried to reboot the cns, but it is stuck in bios.No patient harm was reported.Nihon kohden technician advised the bme that it sounded like the harddrives had failed and needs to be returned to nihon kohden for service.The bme is returning the cns to nihon kohden for evaluation and service.

• 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: 14145817
• MDR Text Key: 290002132
• Report Number: 8030229-2022-02784
• 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: 06/03/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• 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: BEDSIDE MONITOR(S); BEDSIDE MONITOR(S)