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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM
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NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM Back to Search Results
Model Number CNS-6801A
Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Event Description
The customer reported having issues with wireless devices dropping out/going into communication loss (comm loss) and now the telemetry (zms) transmitters are dropping into signal loss.There was no patient injury reported.
 
Manufacturer Narrative
The customer reported having issues with wireless devices dropping out/going into communication loss (comm loss) and now the telemetry (zms) transmitters are dropping into signal loss.The customer did not want to troubleshoot, just wanted a ticket number.According to the customer, a device goes into comm loss or signal loss for 1 to 20 seconds.The customer requested onsite support.There was no patient injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for device information: no reply was received.
 
Manufacturer Narrative
Details of complaint: the customer reported having issues with wireless devices dropping out/going into communication loss (comm loss) and now the telemetry (zms) transmitters are dropping into signal loss.The customer did not want to troubleshoot, just wanted a ticket number.According to the customer, a device goes into comm loss or signal loss for 1 to 20 seconds.The customer requested onsite support.There was no patient injury reported.Investigation summary: nihon kohden was able to confirm the reported issue.Upon on-site troubleshooting, they found intermodulation (two of more different frequencies) and high-power levels witnessed on the b-side of the system from the org closet.The on-site technician added 3db attenuator to output of bs75 and 6db attenuator added to input bs76.The aac bs78 l-band was adjusted to 25.All duplicate channels were removed from the org receivers (12).The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 02/06/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 02/13/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 02/20/2024 emailed the customer via microsoft outlook for device information: no reply was received.Manufacturer references # (b)(4) follow up 001.
 
Event Description
The customer reported having issues with wireless devices dropping out/going into communication loss (comm loss) and now the telemetry (zms) transmitters are dropping into signal loss.There was no patient injury reported.
 
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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 Key18785216
MDR Text Key337418162
Report Number8030229-2024-04137
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921131640
UDI-Public04931921131640
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/29/2024
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 NumberCNS-6801A
Device Catalogue NumberPU-681RA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/26/2024
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received04/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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