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

Model Number CNS-6201A

Device Problems Application Program Problem (2880); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) touch screen was unresponsive and the windows operating system was frozen at the cns software loading screen; she had decided to hold the power button down to perform a reboot.The cns was up and running ten minutes after she shut down the device.Nihon kohden technical support (nk ts) explained to the nurse that performing an ungraceful shutdown can cause the cns to fail completely, and that in the future she should contact a biomed or nk ts prior to rebooting to avoid damaging the device.The nurse also reported that the cns may not have been rebooted in the past three months.The customer said she would communicate the improper reboot event with the biomed.The issue was resolved.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.The following field contains no information (ni), as attempts to obtain information were made, but not provided: email address.Additional device information: concomitant medical device: the following devices were used in conjunction with the cns.Bedside monitors: model #s: ni, sn #s: ni, approximate age of the device: ni, device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that the central nurse's station (cns) was frozen on the windows operating system and cns software loading screen.

Manufacturer Narrative

Complaint details: on 12/08/19 customer (b)(6) from (b)(6) healthcare reported that their device (pu-621ra, sn: (b)(6)) was stuck on the windows os and cns software loading screen, but finally loaded after 10 minutes.Service requested: troubleshoot.Service provided: troubleshoot.Customer noted to tech support that they had performed a "reboot" of their device by force shutting it down "holding the power button down due to the touch screen not being responsive.Tech support advised customer that the long loading time was likely related to this ungraceful shutdown and explained the dangers of forcefully shutting down the machine (could lead to permanent device damage).Investigation conclusion: the issue was resolved after waiting and letting the software load.Customer had ungracefully shut down the device due to the touchscreen becoming frozen.Customer had mentioned that the device may not have been properly restarted in over three months (which is advised in the device operator manual) which may lead to unexpected issues (such as touchscreen glitches).No capa is required as overall risk is low.The probability of re-occurrence is less than 5% and the severity of harm is insignificant.The following field contains no information (ni), as attempts to obtain information were made, but not provided: e1 email address.Additional device information: d11 & c2 concomitant medical device: the following devices were used in conjunction with the cns.Bedside monitors.Model #s: ni.Sn #s: ni.Approximate age of the device: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.

Event Description

The customer reported that the central nurse's station (cns) was frozen on the windows operating system and cns software loading 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: 9533656
• MDR Text Key: 200820795
• Report Number: 8030229-2019-00757
• 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: 03/26/2020

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2020
• Distributor Facility Aware Date: 03/18/2020
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: 12/08/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEDSIDE MONITORS; BEDSIDE MONITORS