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

Model Number	CNS-9700A
Medical Device Problem Codes	No Display/Image (1183); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that the central nurse's station (cns) will power down when they have a power outage/ surge and they have to disconnect the cns power and connect it back in a certain method to get the cns dual monitors back up.Nihon kohden technician had the nurse power cycle the cns, with the dual monitor switch powered on, but the screens stayed black.Nk technician had the nurse power off the dual monitor switch, and both screens came up, currently both screens are working, the staff can hear alarms, and the touchscreen is working.No patient harm or missed events reported.Nihon kohden technician requested that the nurse have their information technology (it) department contact nk technical support to troubleshoot the issue.
Additional Manufacturer Narrative
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 or Problem Description
The nurse reported that the central nurse's station (cns) will power down when they have a power outage/surge and they have to disconnect the cns power and connect it back in a certain method to get the cns dual monitors back up.Nihon kohden technician had the nurse power cycle the cns, with the dual monitor switch powered on, but the screens stayed black.Nk technician had the nurse power off the dual monitor switch, and both screens came up, currently both screens are working, the staff can hear alarms, and the touchscreen is working.No patient harm or missed events reported.Nihon kohden technician requested that the nurse have their information technology (it) department contact nk technical support to troubleshoot the issue.The nurse provided more information that their it department replaced the uninterruptible power supply (ups) which resolved the issue.
Additional Manufacturer Narrative
The nurse reported that the central nurse's station (cns) will power down when they have a power outage/surge, and they have to disconnect the cns power and connect it back in a certain method to get the cns dual monitors back up.Nihon kohden technician had the nurse power cycle the cns, with the dual monitor switch powered on, but the screens stayed black.Nk technician had the nurse power off the dual monitor switch, and both screens came up, currently both screens are working, the staff can hear alarms, and the touchscreen is working.No patient harm or missed events reported.Nihon kohden technician requested that the nurse have their information technology (it) department contact nk technical support to troubleshoot the issue.The nurse provided more information that their it department replaced the uninterruptible power supply (ups) which resolved the issue.Service performed: nihon kohden technical services (nk ts) advised the customer that the issue could possibly be caused by an uninterruptible power supply (ups) malfunction and exchanging the ups might resolve the issue.Investigation summary: investigation determined the complaint record did not involve a failure/malfunction of the nk product.The issue was caused due to the failure of a non-nk manufactured accessory device.No further investigation is needed through the corrective action and or preventative action (capa).The initial medwatch report was sent with the suspect medical device that was documented as a placeholder for the creation of the ticket.Customer provided the correct suspect medical device, model number cns-6801a, catalog number pu-681ra and serial number (b)(6).Corrections: customer provided the correct suspect medical device information d4: model number: corrected to cns-6801a.D4: catalog number: corrected to pu-681ra.D4: serial number: corrected to (b)(6).D4: unique identifier (udi) number: corrected to (b)(4).E3: occupation: nurse.H4: device manufacturer date corrected to 08/04/2010.

• 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 ; 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: 13311568
• Report Number: 8030229-2022-02410
• Device Sequence Number: 4944805
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/25/2022

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
• 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: 12/28/2021
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2010
• 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
• Patient Sex: Unknown