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

Model Number CNS-6801A

Device Problems Display or Visual Feedback Problem (1184); Appropriate Term/Code Not Available (3191); Data Problem (3196)

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

Event Date 06/11/2021

Event Type  malfunction  

Event Description

The customer reported that the central nurse's station (cns) has the issue where the system "locks up" and they can't print, admit and discharge.All review data is missing; however, after the unit is restarted, all normal operation and data comeback, but the issue eventually returns.

Manufacturer Narrative

The customer reported that the central nurse's stations (cns) has the issue where the system "locks up" and they can't print, admit and discharge.All review data is missing.They can still navigate the screen, but some features do not work.Live waveforms will still work, but there's nothing inside full disclosure.The staff has been hard restarting the units to correct the issue, after the restart, all normal operation and data comeback; however, the issue eventually returns after a few hours or 12-24 hours.The unit is being exchanged.There was no patient injury reported.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.

• 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: 12140254
• MDR Text Key: 281355720
• Report Number: 2080783-2021-00398
• 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: 07/08/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2021
• Distributor Facility Aware Date: 06/11/2021
• Device Age: 22 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEDSIDE MONITOR (BSM); GZ TRANSMITTER