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

Model Number CNS-9700A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) failed while monitoring patients.Cns had a hard drive failure and the customer is ordering a replacement.No patient harm 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.Concomitant medical devices: 8 bsm-6301a, serial numbers: (b)(4).

Event Description

The biomedical engineer reported that the central nurse's station (cns) failed while monitoring patients.No patient harm reported.

Event Description

The biomedical engineer reported that the central nurse's station (cns) failed while monitoring patients.No patient harm reported.

Manufacturer Narrative

Details of the complaint on (b)(6) 2019, (b)(6) requested to order a new configured hdd for the cns-9701a (mu-971ra sn:(b)(4)).Service requested troubleshooting/assistance in ordering a new hdd service performed customer ordered a new central station as a replacement.Investigation result the cns was put into service on 09/01/10, which is over 8.5 years prior to the reported issue.Per cns-9701a service manual revision e, the hard disk's expected lifespan is every 2 years and customer is recommended to periodically replace the component.Information of whether this was regularly performed by the customer is not available.A review of device history shows no tickets opened for hdd issues/replacement for this unit.Issues with the hdd could be detected during the performance of regular maintenance inspections every 6 months, as recommended in the cns-9701a service manual.The cns-9701a model was discontinued on 11/14/11 in mbg-111114 due to the introduction of cns-6201a central station.Support for the unit continued for a minimum period of seven years.The issue occurred well beyond the warranty period and promised support period.The unit was not returned and no nka evaluation was performed.Customer purchased a new central station to replace the unit.The root cause is suspected to be maintenance/hdd replacement needed.Due to the age of the unit, this issue is not suspected to be caused by deficient design.D11.Concomitant medical products: there were 8 bed side monitors being used in conjunction with the cns.Model: 6301a serial #'s were not provided by the customer.

• Brand Name: CNS-9700A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8761476
• MDR Text Key: 150123242
• Report Number: 8030229-2019-00260
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• PMA/PMN Number: K023475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2019
• Distributor Facility Aware Date: 09/09/2019
• Device Age: 107 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2019
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: BSM-6301A 8 UNITS; BSM-6301A 8 UNITS