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

Model Number CNS-6201A

Device Problems Use of Device Problem (1670); Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their aten video splitter stopped functioning.The customer bypassed the aten video splitter to get their main monitor to work, but the remote display in the icu was down.The aten box would not power back on.There was likely a brief interruption in patient monitoring during the event when the customer had to disconnect the monitor from the aten device to plug it in directly to the central nurses' station (cns).The cns was monitoring bedside monitors (bsms) and transmitters.Nihon kohden technical service provided the customer with the part information so that she could order another aten from customer service.No patient harm or injury occurred when the displays went out.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.Concomitant medical device: the following devices were used in conjunction with the cns and are the devices that did not experience the failure.Bsm devices: model #: ni, sn #: ni, approximate age of the device: ni, device manufacturer date: ni, unique identifier (udi) #: ni.Transmitters: model #: ni, sn #: ni, approximate age of the device: ni, device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that their aten video splitter stopped functioning.The customer bypassed the aten video splitter to get their main monitor to work, but the remote display in the icu was down.The aten box would not power back on.There was likely a brief interruption in patient monitoring during the event when the customer had to disconnect the monitor from the aten device to plug it in directly to the central nurses' station (cns).

Event Description

The customer reported that their aten video splitter stopped functioning.The customer bypassed the aten video splitter to get their main monitor to work, but the remote display in the icu was down.The aten box would not power back on.There was likely a brief interruption in patient monitoring during the event when the customer had to disconnect the monitor from the aten device to plug it in directly to the central nurses' station (cns).

Manufacturer Narrative

Details of complaint: the customer reported that the aten video splitter stopped functioning.The customer bypassed the aten video splitter to get the central nurse's station (cns) main monitor to work, but the remote display in the icu was down.The aten box would not power back on.There was likely a brief interruption in patient monitoring during the event when the customer had to disconnect the monitor from the aten device to plug it in directly to the central nurses' station (cns).The cns was monitoring bedside monitors (bsms) and transmitters.Nihon kohden technical service provided the customer with the part for a replacement aten video splitter.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: the device was not returned for physical evaluation and functional analysis.The loss of video at the cns was attributed to a failing video splitter.The splitter was not returned for evaluation and as such, the root cause for its failure could not be determined.Due the age of the device, it is possible that the failure was caused by normal wear and tear.It is also possible that the splitter had become damaged due to user mishandling.The splitter is a third-party component.As this issue has an overall risk score of medium, a capa is not required per corrective action and preventive action process, sop07-003.

• 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
• MDR Report Key: 9419822
• MDR Text Key: 194963674
• Report Number: 8030229-2019-00699
• 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: 12/05/2019,10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 12/05/2019
• Distributor Facility Aware Date: 11/08/2019
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2019
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSM DEVICES; BSM DEVICES; TRANSMITTERS; TRANSMITTERS