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

Model Number CNS-6201A

Device Problems Data Problem (3196); Patient Data Problem (3197)

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

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) shows a green blob instead of a waveform for one patient's tile.The nurse reported they still see the green blob moving across the screen though and the issue is only on one patient, but can be seen from the bedside or the cns.No patient harm was reported.Nihon khden technician has made several attempts to gather more information but the nurse has not responded.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 contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2-a3 b6-b7 d10.

Event Description

The nurse reported that the central nurse's station (cns) shows a green blob instead of a waveform for one patient's tile.The nurse reported they still see the green blob moving across the screen though and the issue is only on one patient, but can be seen from the bedside or the cns.No patient harm was reported.Nihon khden technician has made several attempts to gather more information but the nurse has not responded.

Manufacturer Narrative

Details of complaint: the nurse reported that the central nurse's station (cns) shows a green blob instead of a waveform for one patient's tile.The nurse reported they still see the green blob moving across the screen though and the issue is only on one patient, but can be seen from the bedside or the cns.No patient harm was reported.Nihon kohden technician has made several attempts to gather more information but the nurse has not responded.Investigation summary: multiple requests for additional information were sent to the customer, but the customer has been unresponsive.A definitive root cause for this issue could not be determined since we could not duplicate the complaint.Complaint history review for nk patient monitoring devices did not show any other complaints for "blob" or "bubble".Review of this complaint device's serial number (1346) shows that the device is 7 years old and has had two previous instances of hard drive failure and both were resolved through hard drive replacements.Due to the age of the device, wear-and-tear may be a likely contributing factor to any possible hardware issues related to this complaint.Review of the customer's complaint history does not show any recurrence or other similar complaints.Nihon kohden will continue to monitor and trend similar complaints.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1 06/08/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 06/14/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 06/20/2023 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) shows a green blob instead of a waveform for one patient's tile.The nurse reported they still see the green blob moving across the screen though and the issue is only on one patient, but can be seen from the bedside or the cns.No patient harm was reported.Nihon kohden technician has made several attempts to gather more information but the nurse has not responded.

• Brand Name: CNS-6201A
• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17187936
• MDR Text Key: 317730082
• Report Number: 8030229-2023-03632
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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.