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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 11/26/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) went into communication loss with connected devices and when they checked out the org, they saw that it has an error light lit on it.No patient harm was reported.They will be sending this org in for an exchange.
 
Manufacturer Narrative
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.
 
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) went into communication loss with connected devices and when they checked out the org, they saw that it has an error light lit on it.No patient harm was reported.They will be sending this org in for an exchange.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the multiple patient receiver (org) went into communication loss with connected devices and when they checked out the org, they saw that it has an error light lit on it.No patient harm was reported.They will be sending this org in for an exchange.Evaluation of a similar device that was returned for the same reported issue of org going into communication loss was tested by nihon kohden repair center and it was found that the units software was the likely cause for the reported communication loss.Nkrc replaced the software in the unit which was tested and passed all functional tests.Investigation summary: an error message would appear on the device which would alert the clinicians to the issue in which alternate monitoring method could be prepared.As logs were not retrieved, root cause cannot be determined.The cause of the issue is likely to be related to the software on the org.Due to the low occurrence of the reported issue, it is unlikely that the cause of the issue is related to the design of the org software.The software was possibly corrupted due to improper shutdowns or power loss.Last reported complaint for error light on the org was reported on 11/26/2021.Further action is not warranted.Attempt # 1: 11/30/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/21/2021 emailed the customer via microsoft outlook for patient information: customer replied that they are not able to provide information requested.
 
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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
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key13066720
MDR Text Key284648328
Report Number8030229-2021-02224
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 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
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
Date Manufacturer Received08/25/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/20/2013
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.; NI.
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