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

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) screen had gone blank.Tech support (ts) did some troubleshooting with them but the issue persisted.This cns also has a kvm attached to it which mirrors the screen in the hallway.They also were unable to locate the cns device information.Ts and qa have contacted the customer to see if the issue has been resolved, but they have been unresponsive to questions.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)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6)2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The nurse reported that the central nurse's station (cns) screen had gone blank.Tech support (ts) did some troubleshooting with them but the issue persisted.This cns also has a kvm attached to it which mirrors the screen in the hallway.They also were unable to locate the cns device information.Ts and qa have contacted the customer to see if the issue has been resolved, but they have been unresponsive to questions.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the nurse reported that the screen for the central nurse's station (cns) had gone blank.Troubleshooting with technical support (ts) did not resolve the issue.No patient harm was reported.Investigation summary: the customer was contacted to provide additional information, but the requests were left unanswered.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.The customer had a kvm solution for their cns and rns displays.A complaint history review of the customer's account does not reveal similar complaints.It is possible that the cable connections with the kvm were unseated or the kvm had become defective.A hardware failure could come as a result of physical damage, fluid damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Fluid intrusion would result in electrical damage to internal components as well as possible corrosion.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Attempt #1 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The nurse reported that the screen for the central nurse's station (cns) had gone blank.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: 15246001
• MDR Text Key: 304838928
• Report Number: 8030229-2022-03058
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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: 07/19/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 11/28/2023
• 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