MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that their hospital had a brief power-outage after which the central nurse's station (cns) powered back on to a black screen.The cns was monitoring variety of telemetry devices at the time.There was no patient harm or injury reported.Nihon kohden technical services advised the customer to replace the primary hard drive with the secondary drive which allowed the cns to successfully power back into the software.The customer will be ordering new back up drives to mitigate this issue.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.Additional model information: variety of telemetry devices were used in conjunction with the cns, and are not the devices that experienced failure.Attempts to obtain the following information were made, but not provided: telemetry devices model: ni, s/n: ni, approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.), device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The biomedical engineer reported that their hospital had a brief power-outage after which the central nurse's station (cns) powered back on to a black screen.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) medical center reported the cns (pu-621ra sn: (b)(6) ) shut down while monitoring telemetry devices in the ed.The hospital had a power outage and upon powering the cns back on, the unit displayed a black screen.Service requested: troubleshooting/assistance.Service performed: nka technical support (ts) worked with the customer to successfully power on the cns by replacing the primary drive with the secondary drive.Customer was provided part number to order a backup hard drive.Investigation result: the cns warranty began 12/16/15.The issue was reported after approximately 4 years at customer facility.The root cause is determined to be conditions at the facility which caused loss of power to the cns.Sudden loss of power leading to improper shut down of the cns has potential to cause corruption or degradation of the unit's software or parts.Troubleshooting identified an issue with the unit's hard drive.The cns-6201a uses a dual hard drive system with a raid controller.This system provides redundancy on the hard drive to prevent data loss or system failure caused by a failed hard drive.Issue was resolved by replacing the primary drive with the secondary drive to allow the cns to rebuild its raid.No further issues have been reported for this unit.Investigation conclusion: the root cause is determined to be conditions at the facility which caused loss of power to the cns.Additional model information: d11 & c2: variety of telemetry devices were used in conjunction with the cns, and are not the devices that experienced failure.Attempts to obtain the following information were made, but not provided: telemetry devices model: ni.S/n: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni.Unique identifier (udi) #: ni.

Event Description

The biomedical engineer reported that their hospital had a brief power-outage after which the central nurse's station (cns) powered back on to a black screen.

• Brand Name: CNS-6201A
• 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: 9210976
• MDR Text Key: 199998085
• Report Number: 8030229-2019-00576
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2020
• Distributor Facility Aware Date: 12/26/2019
• Device Age: 49 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2020
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TELEMETRY TRANSMITTER DEVICES; TELEMETRY TRANSMITTER DEVICES