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 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) in their intensive care unit (icu) is displaying a black screen after a power outage, the nurse states they can still hear noises and everything is still going to the database, but the screen remains black after powering back up.No patient harm or injury reported.Nihon kohden technician verified with the nurse that all cables were properly seated, and the screen was not just simply off.Nk technician requested the nurse to have their biomedical engineer to contact nihon kohden technical support to troubleshoot this issue further.No further information has been received.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 nurse reported that the central nurse's station (cns) in their intensive care unit (icu) is displaying a black screen after a power outage, the nurse states they can still hear noises and everything is still going to the database, but the screen remains black after powering back up.No patient harm or injury reported.Nihon kohden technician verified with the nurse that all cables were properly seated, and the screen was not just simply off.Nk technician requested the nurse to have their biomedical engineer to contact nihon kohden technical support to troubleshoot this issue further.No further information has been received.

Event Description

The nurse reported that the central nurse's station (cns) in the intensive care unit (icu) was displaying a black screen after a power outage.After rebooting the cns, it seemed to be running, but the screen was still black.No patient harm or injury reported.

Manufacturer Narrative

Details of complaint: the nurse reported that the central nurse's station (cns) in the intensive care unit (icu) was displaying a black screen after a power outage.After rebooting the cns, it seemed to be running, but the screen was still black.No patient harm was reported.Investigation summary: no further information could be obtained regarding this complaint.As no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.A serial number review of the reported device reveals a later complaint reported on an unrelated issue.This issue, documented in ticket (b)(4), reported issues with ibp waveforms.This would indicate that the device was in use and was no longer experiencing a blank display.As no exchanges or repairs were carried out for this device, it is likely that the customer was able to resolve the issue of blank display without further assistance from nka.The root cause is likely related to power issues, improper cable connection, incorrect settings, use error, or user education.No further issues were reported related to the blank display.Additional information: b4 date of this report.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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14123392
• MDR Text Key: 289783316
• Report Number: 8030229-2022-02765
• 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: 10/20/2023

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: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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