MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problem Power Problem (3010)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their central nurse's station (cns) experienced hdd failure and that they need to purchase new ones in order to mitigate this issue.No hard 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) experienced hdd failure and that they need to purchase new ones in order to mitigate this issue.No hard or injury was reported.

Event Description

The customer reported that their central nurse's station (cns) experienced hdd failure and that they need to purchase new ones in order to mitigate this issue.No hard or injury was reported.

Manufacturer Narrative

Complaint details: on (b)(6) 2021, the customer at (b)(6) ctr reported the following issue with pu-681ra; sn (b)(6) , from patient monitoring: cns experienced hdd failure and that they need to purchase new ones in order to mitigate this issue.Investigation summary: the root cause of the issue is considered to be hard drive failure due to lack of preventative maintenance.Hard drives are routine service component, it is expected to be replaced periodically or as indicated.Hard drive expected useful life is approximately 20,000 hours of use / two years.Approximate age of the device at the time of malfunction was 2.5 years.The overall risk of this event, taking into consideration of severity and probability, is "medium".Investigation of the reported issue found it to have been caused due to overdue maintenance.Hard drives are routine service component, it is expected to be replaced periodically or as indicated (preventative maintenance).This does not suggest nk device deficiency/malfunction.

• Brand Name: CNS-6801A
• 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: 12879569
• MDR Text Key: 283250398
• Report Number: 8030229-2021-02010
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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