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

Model Number CNS-6201A

Device Problems Application Program Problem (2880); Output Problem (3005); Power Problem (3010)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the tiles on the central nurse's station (cns) become greyed out, and the cns stops monitoring the tiles.They correct this problem by going to the monitoring screen and re-adding the tile to the cns.He said that this can happen to any tile, and they will drop off, and the cns stops monitoring them.At first this was happening on two cnss, one in icu and one in ed.They swapped out one of the two with a spare cns unit, but now the spare unit was showing the symptoms as well.They rebooted the cnss but the issue persists.No patient harm 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.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the cns.Central nurse's station: model: cns-6201a, sn: (b)(4).Bedside monitor: model: bsm-6501a, sn: (b)(4).Bedside monitor: model: bsm-6701a, sn: (b)(4).

Event Description

The biomedical engineer reported that the tiles on the central nurse's station (cns) become greyed out, and the cns stops monitoring the tiles.They correct this problem by going to the monitoring screen and re-adding the tile to the cns.He said that this can happen to any tile, and they will drop off, and the cns stops monitoring them.At first this was happening on two cnss, one in icu and one in ed.They swapped out one of the two with a spare cns unit, but now the spare unit was showing the symptoms as well.They rebooted the cnss but the issue persists.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that the tiles on the central nurse's station (cns) became greyed out and the cns stopped monitoring the tiles.They corrected this problem by going to the monitoring screen and re-adding the tiles to the cns.At first this was happening on two cnss, one in icu and one in ed.They swapped out one of the two with a spare cns unit, but now the spare unit was showing these symptoms as well.They rebooted the cnss, but the issue persists.No patient harm or injury was reported.Investigation summary: real-time monitoring remains intact on the bedside monitors and can still alert caregivers to changes in vital signs or heart rhythm.This issue should be easily noticeable, allowing caregivers to find alternate methods of patient monitoring.An nkc investigation found that the issue of tiles disappearing was occurring due to the software having been corrupted.A serial number review of pu-621ra sn:(b)(6) revealed that the customer previous requested blank hdds in which they would mirror with existing hdds.Those older hdds were involved in a power loss event which likely caused issues with software corruption in ticket 102284.As a result, the hdds for sn:(b)(6)were mirrored with corrupted software, leading to missing tiles.The root cause of the missing tiles is software corruption due to power loss.The issue is not confirmed to be a result of a deficiency in the design or manufacturing on the nk device.There was no malfunction of an nk device.

Event Description

The biomedical engineer reported that the tiles on the central nurse's station (cns) became greyed out and the cns stopped monitoring the tiles.They corrected this problem by going to the monitoring screen and re-adding the tiles to the cns.At first this was happening on two cnss, one in icu and one in ed.No patient harm was 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: 12931492
• MDR Text Key: 285997879
• Report Number: 8030229-2021-02055
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• 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
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• 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
• Treatment: BSM-6501A (B)(6).; BSM-6501A (B)(6).; BSM-6701A (B)(6).; BSM-6701A (B)(6).; CNS-6201A (B)(6).; CNS-6201A SN (B)(6).