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

Model Number CNS-6201A

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) was experiencing signal loss in a new department.The customer also stated that they had experienced the issue previously.The customer requested on-site support for evaluation and repair.The cns was monitoring bedside monitors (bsm(s)) with telemetry devices, and a patient receiver device (org).Nihon kohden technical support is awaiting a po from the customer in order to begin servicing the device.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: the following devices were used in conjunction with the cns.Bedside monitors: model #: ni.Sn #: ni.Approximate age of the device: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Telemetry devices: model #: ni.Sn #: ni.Approximate age of the device: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Patient receiver (org).Model #: ni.Sn #: ni.Approximate age of the device: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.

Event Description

The customer reported that the central nurse's station (cns) was experiencing signal loss in a new department.The customer also stated that they had experienced the issue previously.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was experiencing signal loss in a new department and had experienced the issue previously.The customer requested on-site support for evaluation and repair.No patient harm was reported.Service requested / performed: onsite evaluation / repair: a wireless medical telemetry service (wmts) was installed, which resolved the issue.This system was installed on the 1st floor observation and 2nd floor pacu.This indicates that the customer was trying to use telemetry devices in areas that were not able to support their use, which resulted in signal loss.Investigation summary: the overall risk of this event is determined to be medium.This issue was not the result of a device malfunction on an nk device.The root cause of this issue is user error.As this issue has an overall risk score of medium, a capa is not required per corrective action and preventive action process, sop07-003.As this issue is not a result of a malfunction of an nk device, a capa is not required.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns.Bedside monitors (bsm) model #: ni sn: ni approximate age of the device: ni device manufacturer date: ni unique identifier (udi) #: ni telemetry devices (transmitters) model #: ni sn: ni approximate age of the device: ni device manufacturer date: ni unique identifier (udi) #: ni multiple patient receiver (org) model #: ni sn: ni approximate age of the device: ni device manufacturer date: ni unique identifier (udi) #: ni.

Event Description

The customer reported that the central nurse's station (cns) was experiencing signal loss in a new department.The customer also stated that they had experienced the issue previously.

• 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
• MDR Report Key: 9541711
• MDR Text Key: 188836384
• Report Number: 8030229-2020-00003
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 01/02/2020,09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2020
• Distributor Facility Aware Date: 12/10/2019
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2020
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEDSIDE MONITORS; BEDSIDE MONITORS; PATIENT RECEIVER (ORG); PATIENT RECEIVER (ORG); TELEMETRY DEVICES; TELEMETRY DEVICES