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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 Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Protective Measures Problem (3015)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  Death  
Event Description
The customer reported that their staff is under the impression that the central nurse's station (cns) did not alarm when one of their patients expired.No further information was provided at this time.
 
Manufacturer Narrative
The customer reported that their staff is under the impression that the central nurse's station (cns) did not alarm when one of their patients expired.No further information was provided at this time.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: concomitant medical device: the following device was used in conjunction with the cns: bsm: model #: mu-671ra.Serial #: (b)(4).Device manufacturer data: 08/03/2020.Unique identifier (udi) #: (b)(4).
 
Event Description
The customer reported that their staff is under the impression that the central nurse's station (cns) did not alarm when one of their patients expired.No further information was provided at this time.
 
Manufacturer Narrative
The customer reported that their staff is under the impression that the central nurse's station (cns) did not alarm when one of their patients expired.No further information was provided at this time.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.Attempt #1 01/12/2022 emailed customer via microsoft outlook for all items under the no information section.An "unknown" asnwer was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the model #: mu-671ra.Serial #: (b)(6).Device manufacturer data: 08/03/2020.Unique identifier (udi) #: (b)(4).
 
Manufacturer Narrative
Details of complaint: the customer reported that the central nurse's station (cns) did not alarm when one of their patients expired.No further information was provided.No patient harm was reported.Investigation summary: the customer reported there was a patient death and requested to find out if the alarms had been silenced.The device logs were analyzed by a nihon kohden engineer.The alarm report shows alarms were triggered and silenced between 10:33:19am and 11:08:05 am.There was no indication of device malfunction, and no recurrence history for this device.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.G7 adverse event term(s).H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.
 
Event Description
The customer reported that the central nurse's station (cns) did not alarm when one of their patients expired.No further information was provided at this time.
 
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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
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key13518905
MDR Text Key288831232
Report Number8030229-2022-02462
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,Followup
Report Date 05/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
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
Date Manufacturer Received04/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2018
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
BEDSIDE MONITOR (BSM); BEDSIDE MONITOR (BSM); BEDSIDE MONITOR (BSM)
Patient Outcome(s) Death;
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