MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

Device Problems No Audible Alarm (1019); Protective Measures Problem (3015); Noise, Audible (3273); Audible Prompt/Feedback Problem (4020)

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

Event Date 12/22/2021

Event Type  malfunction  

Event Description

The customer reported that there were no audible alarams on the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

The customer rebooted the cns, but when the monitor cameback, it displayed no video input.The customer resolved the issue by setting up another cns (pu-621ra) to monitor the 12 patients they have.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.

Manufacturer Narrative

Details of complaint: the customer reported there were no audible alarms at the central nurse's station (cns).The customer rebooted the cns, but when the monitor came back up, it displayed no video input.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.The customer was able to resolve their issue by replacing the reported cns with a newer model cns.The reported cns was installed at the customer's facility on (b)(6)2011 and has been deemed end-of-life.The device has no previous history of repair or servicing.Due to the age of the device, a root cause is likely related to wear and tear due to aging.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.No quality issues have been identified for the reported issue and device.Nihon kohden will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 - b7 d10 attempt # 1: (b)(6)2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 3 (b)(6)2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The customer reported there were no audible alarms at the central nurse's station (cns).There was no patient injury reported.

• Brand Name: CNS-9700A
• 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: 13311535
• MDR Text Key: 284359684
• Report Number: 8030229-2022-02389
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• 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: 07/17/2023

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
• Device Model Number: CNS-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2010
• 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