MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number	CNS-9700A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that their central nurse's station (cns) is showing communication loss for all monitored tele beds.The customer traced the network cable back to the network switch where he found out that the cable was unplugged from the switch.No harm or injury was 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.Transmitters: model #: ni; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that their central nurse's station (cns) is showing communication loss for all monitored tele beds.The customer traced the network cable back to the network switch where he found out that the cable was unplugged from the switch.No harm or injury was reported.
Event or Problem Description
The customer reported that the central nurse's station (cns) was displaying comm loss for all monitored telemetry transmitters.The customer traced the network cable back to the network switch where he found that the cable was unplugged from the switch.No harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the central nurse's station (cns) was displaying comm loss for all monitored telemetry transmitters.The customer traced the network cable back to the network switch where he found that the cable was unplugged from the switch.No patient harm or injury was reported.Investigation summary: comm loss is an error message displayed on individual bed tiles on the cns that alert clinicians that the connection between the cns and the monitored device has been lost.During troubleshooting, it was identified that a network cable (likely for the org of the telemetry devices) had been unplugged.The issue was resolved after the network cable was plugged back in.The customer indicated there was work being performed in the network closet.Based on the available information, the most probable cause of the issue is user error.Personnel likely had inadvertently unplugged the cable while doing work in the network closet.The issue is related to user error.There was no malfunction of the cns.

• Brand Name: CNS-9700A
• Common Device Name: 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: 12723985
• Report Number: 8030229-2021-01877
• Device Sequence Number: 11758282
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K023475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: CNS-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MULTIPLE TRANSMITTERS; MULTIPLE TRANSMITTERS
• Patient Sex: Unknown