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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER
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NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2020
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme)reported that the multiple patient receiver (org) has weak signal and signal loss reported on telemetry transmitters.They switched the org settings to diversity mode, and replaced the defective antenna on our b-loop to resolve issue.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.Concomitant medical device: the following device(s) were being used in conjunction with the org: central nurse's station: model: cns-9701a; sn: (b)(4).Telemetry transmitter: model: zm-540pa; sn: (b)(4).Telemetry transmitter: model: zm-540pa; sn: (b)(4).
 
Event Description
The biomedical engineer (bme)reported that the multiple patient receiver (org) has weak signal and signal loss reported on telemetry transmitters.They switched the org settings to diversity mode, and replaced the defective antenna on our b-loop to resolve issue.No patient harm was reported.
 
Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) had a weak signal.The telemetry transmitters experienced intermittent signal loss at the central nurse's station (cns).They switched the org settings to diversity mode and replaced the defective antenna on the b-loop to resolve the issue.No patient harm was reported.Investigation summary: nihon kohden technical support (nk ts) performed troubleshooting steps and advised customer to check the antenna for the org and verify that the mode was set to diversity.The customer followed the troubleshooting steps provided by nk ts finding one (1) bad antenna, replaced it, and changed the setting to diversity.No further issues of signal loss were reported.The cause of the signal loss was likely a defective antenna which was used to receive the signal from the transmitters.Antennas are a third-party product.Antenna failure is likely a result of hardware failure.Hardware failure could come as a result of physical, heat, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.There is no evidence of an nk device malfunction.
 
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) had a weak signal.Signal loss was reported with the telemetry transmitters.They switched the org settings to diversity mode and replaced the defective antenna on the b-loop to resolve the issue.No patient harm was reported.
 
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Brand Name
ORG-9100A
Type of Device
MULTIPLE PATIENT RECEIVER
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
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key10979609
MDR Text Key220717372
Report Number8030229-2020-00743
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103883
UDI-Public04931921103883
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071058
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 03/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2010
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
CNS-9701A SN (B)(6); CNS-9701A SN (B)(6); ZM TRANSMITTERS; ZM-540PA SN (B)(6); ZM-540PA SN (B)(6)
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