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

Model Number CNS-6801A

Device Problems No Display/Image (1183); Output Problem (3005)

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

Event Date 03/20/2022

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) main monitors went blank and was off with nothing illuminated.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the nurse, but they were not familiar with the device.Nihon kohden technician had the nurse attempt to power on the cns, but the cns would not respond to the power button.Nk technician advised the nurse to have their biomedical engineer contact nihon kohden to troubleshoot the issue further.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.Attempt #1: (b)(6) 2022 - nihon kohden employee spoke with the customers' biomedical engineer who stated that they had no records or recollection of this issue and could not provide any more information.

Event Description

The nurse reported that the central nurse's station (cns) main monitors went blank and was off with nothing illuminated.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the nurse, but they were not familiar with the device.Nihon kohden technician had the nurse attempt to power on the cns, but the cns would not respond to the power button.Nk technician advised the nurse to have their biomedical engineer contact nihon kohden to troubleshoot the issue further.

Event Description

The nurse reported that the central nurse's station (cns) main monitors went blank and was off with nothing illuminated.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the nurse, but they were not familiar with the device.Nihon kohden technician had the nurse attempt to power on the cns, but the cns would not respond to the power button.Nk technician advised the nurse to have their biomedical engineer contact nihon kohden to troubleshoot the issue further.Further information received from the customer is that a user caused the monitor to turn off by turning off the uninterruptible power supply (ups) connected to the cns.

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) main monitors went blank and was off with nothing illuminated.No patient harm was reported.Nihon kohden technician attempted to troubleshoot the issue with the nurse, but they were not familiar with the device.Nihon kohden technician had the nurse attempt to power on the cns, but the cns would not respond to the power button.Nk technician advised the nurse to have their biomedical engineer contact nihon kohden to troubleshoot the issue further.Further information received from the customer is that a user caused the monitor to turn off by turning off the uninterruptible power supply (ups) connected to the cns.The customer reported that a user caused the monitor to turn off by turning off the uninterruptible power supply connected to the cns.The root cause of the cns monitor turning off is use error.As this issue has an over risk score of medium, corrective action and preventive action (capa) is not warranted as the issue was caused by use error.The following fields are not applicable (na) to the mdr report: d4 lot number & expiration date.G4 device bla number.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.Attempt#: 1: on (b)(6) 2022: nihon kohden employee spoke with the customers' biomedical engineer who stated that they had no records or recollection of this issue and could not provide any more information.On (b)(6) 2022: email from customer stating that the issue was likely due to the button on the uninterruptible power source that this cns is plugged into may have accidentally been pressed causing the monitors to go out.The facility has not had any power issues with this device since this report.Additional information: b4: date of this report.B5: adverse event or product problem.G3: date received by manufacturer.G6: type of report.H2: if follow-up, what type? h6: event problem and evaluation codes.H10: additional manufacturer narrative.

• 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: 14121516
• MDR Text Key: 298818430
• Report Number: 8030229-2022-02766
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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: NA.; NA.