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

Model Number CNS-6201A

Device Problems Application Program Problem (2880); Appropriate Term/Code Not Available (3191); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their central nurse's station (cns) was freezing up.The unit does not have an hdd light showing.They rebooted before they called and the unit is stuck on the cns splash screen.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.

Event Description

The customer reported that their central nurse's station (cns) was freezing up.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was freezing up.The unit did not have an hdd light showing.They rebooted before calling and the unit was stuck on the cns splash screen.No patient harm was reported.Investigation summary: the customer indicated that they have replaced the complaint device.The complaint device had been in service since 06/01/2012.A review of the history of the serial number identified no other reports of this issue.Based on the available information, a definitive root cause could not be identified.However, it is likely that the hdds of the device had failed.Possible causes of hdd failure are power surges/interruptions and wear and tear.Events that involve fluctuations and changes in the voltage such as power outages and generator tests may damage the hdds.The hdds are electronic components/devices that may deteriorate through time and may wear from continual use, requiring proper maintenance.

Event Description

The customer reported that the central nurse's station (cns) was freezing up.

• Brand Name: CNS-6201A
• 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: 11215247
• MDR Text Key: 238970005
• Report Number: 8030229-2021-00022
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2011
• 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