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

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

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

The customer reported that this central nurse's station (cns) display went black and it never started working again.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this central nurse's station (cns) display went black and it never started working again.The customer requested for the unit to be exchanged.There was no patient injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: patient, event & device information requests, attempt # 1: 01/30/2023 emailed the customer via microsoft outlook for information: no reply was received.Patient, event & device information requests, attempt # 2: 02/01/2023 emailed the customer via microsoft outlook for information: the customer replied by stating; i do not have that information.The following fields are not available (n/a) to this report: device pma/510k #; udi.

Event Description

The customer reported that this central nurse's station (cns) display went black and it never started working again.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station (cns) display went black and it never started working again.The customer requested for the unit to be exchanged.There was no patient injury reported.Investigation summary: the complaint device was returned by the customer and was evaluated by nk repair center.The black screen issue was observed.The monitor does not power up and stays as black screen as reported by the customer.The nk repair center indicated that the monitor was no longer repairable.As the device was no longer powering up, the cause of the issue is likely due to the failure of the power board of the monitor.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 01/30/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/01/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have that information.B6 attempt # 1: 01/30/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/01/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have that information.B7 attempt # 1: 01/30/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/01/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have that information.D1 attempt # 1: 01/30/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 02/01/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i do not have that information.D4 - model number, catalog number & serial number attempt # 1: 01/30/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 02/01/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i do not have that information.D10 attempt # 1: 01/30/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 02/01/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i do not have that information.The following fields are not available (n/a) to this report: g4 - 510k d4 - udi 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 manufacturer references # (b)(4)- 162658 follow up 001.

• 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: 16402815
• MDR Text Key: 310350089
• Report Number: 8030229-2023-03291
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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