MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; CENTRAL MONITOR STATION

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but 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.Attempt #1: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but no patient harm was reported.

Manufacturer Narrative

The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but 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: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h10 additional manufacturer narrative the following is not regarding the the device information for the mdr itself, but to explain why this report was not late as the initial mdr was submitted on 03/26//21 at 07:39:32 pm pst pm per webtrader sent box.We also had written to the help desk about this at emdr@fda.Hhs.Gov the mdr was filed on the due date of 03/26/21, but the acknowledgements did not arrive till 03/27/2021.Below are the acknowledgements from the initial submission with the time stamps that illustrate that the mdr was filed on time and not late.Messageid: 16754610.19.1616812770690@bh9c1g2.Coreid: ci1616812773620.6863060@fdsuv08640_te1 datetime receipt generated: 03-26-2021, 22:40:37 "cdrh has received your submission" ack3: this submission has been sent to the production system and has been processed by the fda.Please refer to the summary section below to determine if this submission has passed or failed.Ci1616812773620.6863060@fdsuv08640_te1 8030229-20210326193628 sat mar 27 10:56:48 edt 2021 0 1 form 3500a - icsr r2 passed submission summary environment: ack3: this submission has been sent to the production system and has been processed by the fda.Please refer to the summary section below to determine if this submission has passed or failed.Submission type: form 3500a - icsr r2 core id: ci1616812773620.6863060@fdsuv08640_te1 batch id: 8030229-20210326193628 date entered: sat mar 27 10:56:48 edt 2021 summary: passed: 1, failed: 0 report list: report number: passed.

Event Description

The biomedical engineer reported that one of the displays for the central nurse's station (cns) with the dual display set up has issues.The display was hardly visible and had a green & purple screen and was dying.They replaced the cables, verified the monitor was good and isolated the problem to a defective kvm switch.Under 3 year warranty.In patient use but no patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that one of the displays for the central nurse's station (cns), that was set up for dual display, was failing and data was hard to see.They replaced the cables, verified the monitor was working, and isolated the problem to a defective kvm switch.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Failure of a kvm is likely a result of hardware failure.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.Attempt #1 02/26/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/04/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/12/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer (bme) reported that one of the displays for the central nurse's station (cns), that was set up for dual display, was failing and data was hard to see.No patient harm was reported.

• Brand Name: NI
• Type of Device: CENTRAL MONITOR STATION
• 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: 11579912
• MDR Text Key: 242709250
• Report Number: 8030229-2021-00171
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 09/19/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 03/26/2021; 08/31/2023
• Supplement Dates FDA Received: 04/05/2021; 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NI.; NI.; NI.