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

Model Number CNS-6201A

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

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

Event Date 12/19/2021

Event Type  malfunction  

Manufacturer Narrative

According to the customer, both displays are black.The customer later reported that the screens were back on, but when the unit was rebooted, it got stuck in a boot loop.The unit displayed a "fatal error" and the unit needs to shut down to protect it message.The customer will send in the unit to be repaired.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 the central nurse's station (cns) shut down and will not power back on.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) shut down and would not power back on.Both displays were black.They later reported that the screens were back on, but when the unit was rebooted, it got stuck in a boot loop.The unit displayed a "fatal error" message.The customer sent the unit in for repair.No patient harm was reported.Investigation summary: during the evaluation of the returned device nihon kohden repair center (nk rc) was not able to duplicate the issue of cns not booting into the software.No issues were observed during the evaluation.It was noted that the cns was an older model and replacement of the hard drives due to age was recommended.It is likely that the reported issue of sudden shut down was a result of a failing hard drive.The event is likely to be intermittent as it was not observed during evaluation.However, a root cause cannot be determined.The customer requested that the unit be scrapped as they no longer required the device.The hdds are electronic components that may deteriorate through time and may wear from continual use.Possible causes of failure include mechanical failure from improper use/handling, corruption of the files from abnormal shutdowns or viruses, or power issues.Other possible causes of the issue are power surges/interruptions and wear and tear.Complaint history review of the customer's account does not reveal any complaints relating to sudden shutdowns.This event is likely an isolated incident and there is no evidence indicating a trend for unintentional shutdown events.Additional information: b4 date of this report d9 device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The customer reported that the central nurse's station (cns) shut down and would not power back on.There was no patient injury reported.

• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13268777
• MDR Text Key: 286771714
• Report Number: 8030229-2022-02337
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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