MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems No Display/Image (1183); Output Problem (3005)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurses station (cns) screen was black.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurses station (cns) screen was black.Technical support (ts) found during troubleshooting that the monitor was not receiving power.However, they would need to determine if the issue was the cable going to the monitor or if it was the monitor itself.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 the information were made, but none were provided.A2 - a6.B6.B7.D10.Attempt #1.06/15/2023 emailed bme for all items under the no information section and the concomitant medical devices.No reply was received.Attempt #2.06/20/2023 emailed bme for all items under the no information section and the concomitant medical devices.No reply was received.Attempt #3 06/27/2023 emailed bme for all items under the no information section and the concomitant medical devices.No reply was received.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: bsm(s): model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Transmitter(s).Model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurses station (cns) screen was black.Technical support (ts) found during troubleshooting that the monitor was not receiving power.However, they would need to determine if the issue was the cable going to the monitor or if it was the monitor itself.Investigation summary: multiple follow-up 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 the device has not been returned for evaluation and we could not duplicate the complaint.Based on the troubleshooting details, possible causes may include cable issues or hardware component failure.The display monitor may not work properly if cables are loose or damaged from user mishandling.Hardware component failure can occur through physical damage or fluid intrusion from user mishandling, power issues from outages or surges, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number shows that the device is 3 years old and has no other complaints.Review of the customer's complaint history showed 1 similar complaint under ticket 133731 in which the screen went blank intermittently, but a root cause was not determined since the issue resolved spontaneously and the customer opted not to send the device in for evaluation.The customer complaint history review did not show any trends.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but none were provided.A2 - a6 b6 b7 d10 attempt #1 06/15/2023 emailed bme for all items under the no information section.No reply was received.Attempt #2 06/20/2023 emailed bme for all items under the no information section.No reply was received.Attempt #3 06/27/2023 emailed bme for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: bsm(s): model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na transmitter(s) model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na 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 biomedical engineer (bme) reported that the central nurses station (cns) screen was black.No patient harm was reported.

• Brand Name: CNS-6801A
• 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: 17280577
• MDR Text Key: 318707107
• Report Number: 8030229-2023-03646
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• 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: BSM(S); BSM(S); TRANSMITTER(S); TRANSMITTER(S)