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

Model Number CNS-6201A

Device Problems Loss of Power (1475); Communication or Transmission Problem (2896); Electrical Power Problem (2925)

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

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) is displaying communication loss.Nihon kohden technical support advised the customer to go to the multiple patient receiver (org) closet where they found that all of the org's where powered off.This happened due to a bad uninterruptible power supply (ups).Once they bypassed the ups and went directly into dc power, the org's came back up.No harm or injury was reported.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 model information: multiple org's were used in conjunction with the cns, and are not the devices that experienced failure.Attempts to obtain the following information were made, but not provided: org's: model: ni, s/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.A ups was used in conjunction with the cns, and it is the device that experienced failure.Attempts to obtain the following information were made, but not provided: ups: model: ni, s/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that the central nurse's station (cns) is displaying communication loss.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was displaying comm loss.Nihon kohden technical support (nk ts) advised the customer to check the multiple patient receiver (org) in the closet and they found that all the orgs were powered off.This was caused by a bad uninterruptible power supply (ups), which had failed.Once they bypassed the ups and plugged it directly into a wall outlet, the orgs came back up.No patient harm or injury was reported.Service requested / performed: troubleshooting.Investigation summary: communication loss is an error message displayed on individual bed tiles on the cns that alert clinicians that the connection between the cns and the device its monitoring has been lost.During troubleshooting, it was identified that the org for the telemetry devices was plugged into a failed ups.The org was plugged directly into a wall power outlet, which resolved the issue.The cns has been in service since 05/24/2014, and there have been no other reports of communication loss.Based on the available information, the cause of the communication loss issue is ups power failure.Possible causes of the ups failure are power surges, inadequate ups maintenance, and normal wear and tear.Furthermore, available information does not suggest that there was a malfunction of this device.

Event Description

The customer reported that the central nurse's station (cns) was displaying comm loss.

• 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: 10382760
• MDR Text Key: 204412351
• Report Number: 8030229-2020-00442
• 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: 08/07/2020,09/07/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2020
• Distributor Facility Aware Date: 07/14/2020
• Device Age: 75 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2014
• 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
• Treatment: MULTIPLE MULTIPLE PATIENT RECEIVER'S(ORG'S); MULTIPLE MULTIPLE PATIENT RECEIVER'S(ORG'S); UNINTERRUPTIBLE POWER SUPPLY (UPS); UNINTERRUPTIBLE POWER SUPPLY (UPS)