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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER
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NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2023
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing a communication loss at the central nurse station for their telemetry transmitter (teles).The bme stated that when they went to the org, they noticed the error led light was on.The error led light goes from a flashing light to a solid light (back and forth).The bme rebooted the org, but the issue persisted.This issue was discovered while in use but, the tele's are back up due to the customer having a loaner unit at their facility.No patient harm was reported.The biomedical engineer requested to send the unit for repair.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing a communication loss at the central nurse station for their telemetry transmitter (teles).The bme stated that when they went to the org, they noticed the error led light was on.The error led light goes from a flashing light to a solid light (back and forth).The bme rebooted the org, but the issue persisted.This issue was discovered while in use but, the tele's are back up due to the customer having a loaner unit at their facility.No patient harm was reported.The biomedical engineer requested to send the unit for repair.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: (b)(6) 2023: emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023: emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2023: emailed the customer via microsoft outlook for patient information: no reply was received.
 
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing a communication loss at the central nurse station for their telemetry transmitter (teles).The bme stated that when they went to the org, they noticed the error led light was on.The error led light goes from a flashing light to a solid light (back and forth).The bme rebooted the org, but the issue persisted.This issue was discovered while in use but, the tele's are back up due to the customer having a loaner unit at their facility.No patient harm was reported.The biomedical engineer requested to send the unit for repair.
 
Manufacturer Narrative
Complaint summary: the biomedical engineer (bme) reported that the multiple patient receiver (org) was showing a communication loss at the central nurse station for their telemetry transmitter (teles).The bme stated that when they went to the org, they noticed the error led light was on.The error led light goes from a flashing light to a solid light (back and forth).The bme rebooted the org, but the issue persisted.This issue was discovered while in use but, the tele's are back up due to the customer having a loaner unit at their facility.No patient harm was reported.The biomedical engineer requested to send the unit for repair.Investigation summary: nk repair center (rc) evaluated the unit on 10/24/2023 and duplicated the complaint.The error led was flashing on.No physical damage or fluid intrusion observed.Nk rc initialized the unit and checked the transmissions and reception.No problems were observed during the extended testing period.A definitive root cause could not be determined since communication loss was not observed during evaluation.Review of the complaint device's serial number shows a previous occurrence in which we were able to duplicate the complaint and repair the device by initializing the unit.Possible causes may include incompatible software versions between the org and cns, or user error with the org's network settings such as incorrect network communication protocol.The customer should ensure devices within the patient monitoring network are on compatible software versions and on the same net protocol setting.A possible cause of the error light may be related to the backup ram which stores system settings.The org-9100 service manual recommends initialization to troubleshoot error lights related to the backup ram.Memory processing components may become corrupt due to ungraceful shutdown, power outages, or user error while upgrading software.Review of the complaint device's serial number does not show recurrence since the unit was sent back to the customer.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 08/25/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 08/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 09/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.
 
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Brand Name
ORG-9110A
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
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key17770003
MDR Text Key324225702
Report Number8030229-2023-03782
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/14/2023
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 NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/25/2023
Initial Date FDA Received09/18/2023
Supplement Dates Manufacturer Received12/13/2023
Supplement Dates FDA Received12/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2020
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
CNS.; CNS.; ZM TRANSMITTERS.; ZM TRANSMITTERS.
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