MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was rebooted and when it came back up, all the bed-tiles displayed the message "system failure".No patient harm was reported.Nihon kohden technician requested the bme to press the silence alarm button on each of the bedside monitors and when they did that resolved the failure message on the cns.Nk technician advised the bme that the device has reached the end of life expectancy.

Manufacturer Narrative

Bedside monitor: model #: ni, serial #: ni, device manufacturer data: ni.

• Brand Name: CNS-9700A
• 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: 13122730
• MDR Text Key: 286335500
• Report Number: 2080783-2021-02277
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/30/2021

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-9700A
• Device Catalogue Number: MU-971RA
• 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: 12/30/2021
• Distributor Facility Aware Date: 12/08/2021
• Device Age: 184 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSM