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

Model Number CNS-6201A

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) was not producing sounds through the display speakers.After initial troubleshooting, the customer found that the audio cable was plugged into the wrong port.Once the cable was plugged back into the correct port, the sound was restored.There was no malfunction of the device.No harm or injury 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.

Event Description

The customer reported that the central nurse's station (cns) was not producing sounds through the display speakers.

Event Description

The customer reported that the central nurse's station (cns) was not producing sounds through the display speakers.

Manufacturer Narrative

Details of complaint: on (b)(6) 2020 customer biomed stated that no sound was coming from the speakers.Customer checked the volume settings, sound cable connections, and restarting the cns device.On (b)(6) 2020 customer stated that the sound cable was plugged into the wrong port.Once the cable was plugged in correct port, no issues were observed.Investigation summary: the root cause of the sound issue was due to cable being plugged into the wrong port.History shows this is the first incident on this device since it was put into service in 2015.No capa is required.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9690700
• MDR Text Key: 195419789
• Report Number: 8030229-2020-00071
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2020
• Distributor Facility Aware Date: 03/16/2020
• Device Age: 108 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1