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  

Manufacturer Narrative

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.

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.Investigation summary: biomedical engineer reported that the cns went into communication loss (comm loss) with all connected bsm devices.During troubleshooting, the bme identified that the switch for the cns was not powered on.In a follow up with the customer, the bme indicated that there was a power outage that caused the ups to fail.The switch that was not powered on was connected to the ups.The available information does not suggest that there was a malfunction of the cns device, therefore a corrective action or preventative action (capa) is not necessary.Attempt #1, 09/23/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2, 10/07/2021 emailed customer via microsoft outlook for all items under the no information section.Customer replied but did not provide the requested information.

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.

• 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
• 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: 12635109
• MDR Text Key: 283594026
• Report Number: 8030229-2021-01814
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: 06/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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 (BSM); BEDSIDE MONITOR'S (BSM)