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

Model Number CNS-6201A

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the power went out in some parts of the hospital and the power was down long enough to drain the uninterrupted power supply (ups) back up battery power causing the central nurse's station (cns) to be stuck in the splash screen.The bme stated that the nurses are still able to pull the patient information off of the bedside monitors (bsm) in this department, so no missed events or patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue, but the customer declined and stated they would be sending the device into nihon kohden for service.

Manufacturer Narrative

Nihon kohden service department cleaned and decontaminated the customer's device, discovered lots of dust inside the unit.Verified the reported issue, unit does not boot up to the cns application.Hard drives (hdd) are degrading and need to be replaced.Pending approval from customer.Concomitant medical device: the following device(s) were used in conjunction with the cns; however the model and serial numbers are no information (ni) as attempts were made as documented, but none were provided.Bedside monitors: model #: ni, serial #:ni, device manufacturer data: ni.Uninterrupted power supply: model #: ni, serial #: ni.

Event Description

The biomedical engineer (bme) reported that the power went out in some parts of the hospital and the power was down long enough to drain the uninterrupted power supply (ups) back up battery power causing the central nurse's station (cns) to be stuck in the splash screen.The bme stated that the nurses are still able to pull the patient information off of the bedside monitors (bsm) in this department, so no missed events or patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue, but the customer declined and stated they would be sending the device into nihon kohden for service.

Manufacturer Narrative

The biomedical engineer (bme) reported that the power went out in some parts of the hospital and the power was down long enough to drain the uninterrupted power supply (ups) back up battery power causing the central nurse's station (cns) to be stuck in the splash screen.The bme stated that the nurses are still able to pull the patient information off of the bedside monitors (bsm) in this department, so no missed events or patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue, but the customer declined and stated they would be sending the device into nihon kohden for service.Nihon kohden service department cleaned and decontaminated the customer's device, discovered lots of dust inside the unit.Verified the reported issue, unit does not boot up to the cns application.Hard drives (hdd) are degrading and need to be replaced.Device was repaired, tested and passed all tests and was returned to customer.Investigation conclusion: the device was put into service on 03/20/2016.The service history for this serial number shows no similar reports or tickets.The unit had no physical damage, but the device suffered from a power outage, which inadvertently caused the harddrives to crash.Risk analysis shows the risk score is medium.As such, no corrective actions would be warranted at this time.Attempt #1 12/20/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 12/23/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 01/07/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns; however the model and serial numbers are no information (ni) as attempts were made as documented, but none were provided.Bedside monitors: model #: ni.Serial #:ni.Device manufacturer data: ni.Additional information: b4: date of this report.D10: suspect medical device removed uninterrupted power supply (not a medical device).G3: date received by manufacturer.G6: type of report.H2: if follow-up, what type? h10: additional manufacturer narrative.

• 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: 13237352
• MDR Text Key: 286014261
• Report Number: 8030229-2022-02309
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• 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 MONITORS (BSM).; BEDSIDE MONITORS (BSM).; UNINTERRUPTED POWER SUPPLY (UPS).