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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 Computer Software Problem (1112); Unintended Application Program Shut Down (4032)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(6) reported that the central nurse's station (cns) randomly shut down on its own.(b)(6) tried to boot up the cns with one hard drive at a time and just heard the internal fan blowing at full speed but still did not see any video being displayed.Bme stated that these cns monitors are directly connected to the cpu tower.Biomed swapped out to another monitor and still no video display from the monitor, he also tried one monitor being plugged in, but the issue persisted.No patient harm was reported.Nihon kohden technician advised the bme that it seems like the cpu tower is not getting past the bios stage of the bootup stage.Nk technician recommended that the bme send the unit into nihon kohden repair center for repair and provided the bme with a return material authorization to return it.Evaluation summary: on (b)(6) 2024 pu-681ra sn (b)(6) was received at nihon kohden repair center (nkrc) and the unit was cleaned and decontaminated, no physical damage or fluid intrusion found in the unit.Unit was tested for the reported complaint of device randomly shutting down and issue was duplicated.Nkrc replaced two hard disc drives in the device tested per operator's manual for 24 hours and operates to manufacturer's specifications.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 not provided: a2 - a6.B6 - b7.D10.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from biomed who stated "fortunately we did not have anyone on the monitoring system at the time it went down".He did not provide any further information requested information.
 
Event Description
(b)(6) reported that the central nurse's station (cns) randomly shut down on its own.(b)(6) tried to boot up the cns with one hard drive at a time and just heard the internal fan blowing at full speed but still did not see any video being displayed.Bme stated that these cns monitors are directly connected to the cpu tower.Biomed swapped out to another monitor and still no video display from the monitor, he also tried one monitor being plugged in, but the issue persisted.No patient harm was reported.Nihon kohden technician advised the bme that it seems like the cpu tower is not getting past the bios stage of the bootup stage.Nk technician recommended that the bme send the unit into nihon kohden repair center for repair and provided the bme with a return material authorization to return it.
 
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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 Key18500036
MDR Text Key332773089
Report Number8030229-2024-04004
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2024
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NI.
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