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

Model Number CNS-9700A

Device Problems No Display/Image (1183); Complete Loss of Power (4015)

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

Event Date 12/28/2021

Event Type  malfunction  

Event 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.

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 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.

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
• 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: 13311568
• MDR Text Key: 286532991
• Report Number: 8030229-2022-02410
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2010
• 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