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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NKUS LAB RNS-6803-7450; REMOTE NETWORK STATION

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NKUS LAB RNS-6803-7450; REMOTE NETWORK STATION Back to Search Results
Model Number RNS-6803-7450
Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2019
Event Type  malfunction  
Manufacturer Narrative
The customer reported that their war room remote network system (rns) was showing communication loss on a variety of telemetry beds.The customer also reported that the rns feed was coming from a central nurse's station (cns) located at their secondary facility.Attempts to obtain further information in regards to this issue were made, but not provided.No harm or injury 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 model information: the following devices were used in conjunction with the rns, but it is unclear if they experienced failure.Attempts to obtain the following information were made, but not provided: variety of telemetry devices - model: ni, s/n: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni, unique identifier (udi) #: ni.Cns - model: ni, s/n: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni, unique identifier (udi) #: ni.
 
Event Description
The customer reported that their war room remote network system (rns) was showing communication loss on a variety of telemetry beds.
 
Manufacturer Narrative
Details of complaint: on (b)(6) 2019 customer stated that cns device was displaying communication loss for several telemetry beds being monitored.A remote monitor rns-6803 s/n (b)(6) that was feeding off the cns was displaying communication loss for 10 patients.Investigation summary: due to no response from customer and insufficient information available.The cause of the reported communication loss could not be determined.The issue has not re-occurred.No capa is required at this time.Additional model information: d11 & c2: the following devices were used in conjunction with the rns, but it is unclear if they experienced failure.Attempts to obtain the following information were made, but not provided: variety of telemetry devices - model: ni.S/n: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni.Unique identifier (udi) #: ni.Cns - model: ni.S/n: ni.Approximate age of the device: ni (no serial number was provided, so the age of the device is unknown.) device manufacturer date: ni.Unique identifier (udi) #: ni.
 
Event Description
The customer reported that their war room remote network system (rns) was showing communication loss on a variety of telemetry beds.
 
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Brand Name
RNS-6803-7450
Type of Device
REMOTE NETWORK STATION
Manufacturer (Section D)
NKUS LAB
14 bunsen
attn: shama mooman
irvine, ca CA 92618
MDR Report Key9312749
MDR Text Key167967382
Report Number2032233-2019-00644
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00851725007153
UDI-Public00851725007153
Combination Product (y/n)N
PMA/PMN Number
K102376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 03/16/2020
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 NumberRNS-6803-7450
Device Catalogue NumberRNS-6803-7450
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/15/2019
Initial Date FDA Received11/12/2019
Supplement Dates Manufacturer Received03/13/2020
Supplement Dates FDA Received03/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CNS; CNS; VARIETY OF TELEMETRY DEVICES; VARIETY OF TELEMETRY DEVICES
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