MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Electrical /Electronic Property Problem (1198); Loss of Power (1475); Communication or Transmission Problem (2896)

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

Event Date 09/20/2021

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) and the bedside monitor (bsm's) went into communication loss, the bme went to one of the rooms and could not see any beds in interbed.No patient harm reported.Nihon kohden technician asked the bme to go to the communication closet that these units are patched to and make sure these units are up.The bme discovered that the cisco switch was not powered on.The customer later reported that there was a power outage that took out the uninterruptible power supply (ups) that the devices were plugged into, so those devices were not getting any connectivity, issue has been resolved.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) and the bedside monitor (bsm's) went into communication loss, the bme went to one of the rooms and could not see any beds in interbed.No patient harm reported.Nihon kohden technician asked the bme to go to the communication closet that these units are patched to and make sure these units are up.The bme discovered that the cisco switch was not powered on.The customer later reported that there was a power outage that took out the uninterruptible power supply (ups) that the devices were plugged into, so those devices were not getting any connectivity, issue has been resolved.

• Brand Name: CNS-6801A
• 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: 12635049
• MDR Text Key: 281436802
• Report Number: 2080783-2021-01814
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Distributor Facility Aware Date: 09/20/2021
• Device Age: 27 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEDSIDE MONITOR'S (BSM)