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

Model Number CNS-6201A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that this central nurses station (cns) intermittently went into communication loss every five (5) minutes.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that this central nurses station (cns) intermittently went into comm loss every five (5) minutes.Technical support (ts) verified that they had a secondary monitor, a remote network station (rns), in place monitoring these same telemetry devices without an issue, which indicated the issue was not with the multiple patient receiver (org).Bme cleaned the cns from dirt and dust, reseated the network cable, and tried a known working network port from the same room, but the issue persisted.No patient harm 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.Additional device information: d10 concomitant medical device: rns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Org: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Telemetry transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Bsm(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 nurse's station (cns) intermittently went into comm loss every five (5) minutes.Technical support (ts) verified that they had a secondary monitor, a remote network station (rns), in place monitoring these same telemetry devices without an issue, which indicated the issue was not with the multiple patient receiver (org).The bme cleaned the dirt and dust from the cns, reseated the network cable, and tried a known working network port from the same room, but the issue persisted.No patient harm was reported.Investigation summary: the reported device was sent in for evaluation and repair.On 10/17/2023, the unit was cleaned and decontaminated.Nihon kohden repair center (nk rc) was unable to duplicate the reported issue, and the device passed extended testing for forty-eight hours, with no issue or error.On (b)(6) 2023, the customer requested that the device be tested extensively before concluding there is no problem with it and recommend testing the unit with a full load of telemetry units.On 10/30/2023, during the extended testing of 72 hours, it was discovered that the storage file was corrupt.Nk rc replaced the hdds to resolve the issue.When the customer received the repaired device, they reported they received the same "storage file corruption" error and stated they wanted to send the device back for repair.Ticket (b)(4) was created to document the return.Ts followed up with the customer on (b)(6) 2024 regarding not having received a holding purchase order (po) for the loaner or the defective cns unit (sn: (b)(6).Nk determined the root cause to be hdd issues.Typically, hdd issues occur due to damage to the hdd as it is not shockproof, and mishandling can easily damage internal components of the hdd.Accidental drops or hard impacts can damage internal components of the hdd.Damage to the hdd can also be caused by power issues, such as a power surge, or due to mechanical stress from wear and tear and degradation due to aging.During a review of the device history for the reported issue, we found three similar issues, for similar devices (product id: pu-621ra), that occurred at this facility around the same time frame.These similar complaints were discovered over the past year and are as follows: ticket #: (b)(4) (reported on 09/11/2023 sn: (b)(6), ticket#: (b)(4) (reported on 09/18/2023 sn: (b)(6) and ticket#: (b)(4) (reported on 11/29/2023 sn: (b)(6).A review of the device history does not reveal a significant trend that would contribute to component failure that is related to the design or manufacturing of the device.Nk will continue to monitor trends for this device and facility for similar complaint issues.Additional information: b4: date of this report.D9: device available for evaluation? g3: date received by manufacturer.G6: type of report.H2: if follow-up, what type? h3: device evaluated by manufacturer? h6: event problem and evaluation codes.H11: additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) intermittently went into comm loss every five (5) minutes.No patient harm was reported.

• 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: 17894591
• MDR Text Key: 325601326
• Report Number: 8030229-2023-03825
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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).; BSMS.; ORG.; ORG.; RNS.; RNS.; TELEMETRY TRANSMITTERS.; TELEMETRY TRANSMITTERS.